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openfda_device_searcher

Query the FDA's MAUDE database to identify medical device issues, including malfunctions, patient injuries, and genomic/diagnostic device problems. Filter by device type, manufacturer, or problem description to uncover adverse event reports.

Instructions

Search FDA device adverse event reports (MAUDE) for medical device issues.

⚠️ PREREQUISITE: Use the 'think' tool FIRST to plan your research strategy!

Searches FDA's device adverse event database for:
- Device malfunctions and failures
- Patient injuries related to devices
- Genomic test and diagnostic device issues

By default, filters to genomic/diagnostic devices relevant to precision medicine.
Set genomics_only=False to search all medical devices.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
api_keyNoOptional OpenFDA API key (overrides OPENFDA_API_KEY env var)
deviceNoDevice name to search for
genomics_onlyNoFilter to genomic/diagnostic devices only
limitNoMaximum number of results
manufacturerNoManufacturer name
pageNoPage number (1-based)
problemNoDevice problem description
product_codeNoFDA product code

Implementation Reference

  • MCP tool handler function 'openfda_device_searcher'. Defines the tool schema with Pydantic annotations, registers via @mcp_app.tool(), and delegates execution to the core search_device_events helper.
    @track_performance("biomcp.openfda_device_searcher")
    async def openfda_device_searcher(
        device: Annotated[
            str | None,
            Field(description="Device name to search for"),
        ] = None,
        manufacturer: Annotated[
            str | None,
            Field(description="Manufacturer name"),
        ] = None,
        problem: Annotated[
            str | None,
            Field(description="Device problem description"),
        ] = None,
        product_code: Annotated[
            str | None,
            Field(description="FDA product code"),
        ] = None,
        genomics_only: Annotated[
            bool,
            Field(description="Filter to genomic/diagnostic devices only"),
        ] = True,
        limit: Annotated[
            int,
            Field(description="Maximum number of results", ge=1, le=100),
        ] = 25,
        page: Annotated[
            int,
            Field(description="Page number (1-based)", ge=1),
        ] = 1,
        api_key: Annotated[
            str | None,
            Field(
                description="Optional OpenFDA API key (overrides OPENFDA_API_KEY env var)"
            ),
        ] = None,
    ) -> str:
        """Search FDA device adverse event reports (MAUDE) for medical device issues.
    
        ⚠️ PREREQUISITE: Use the 'think' tool FIRST to plan your research strategy!
    
        Searches FDA's device adverse event database for:
        - Device malfunctions and failures
        - Patient injuries related to devices
        - Genomic test and diagnostic device issues
    
        By default, filters to genomic/diagnostic devices relevant to precision medicine.
        Set genomics_only=False to search all medical devices.
        """
        from biomcp.openfda import search_device_events
    
        skip = (page - 1) * limit
        return await search_device_events(
            device=device,
            manufacturer=manufacturer,
            problem=problem,
            product_code=product_code,
            genomics_only=genomics_only,
            limit=limit,
            skip=skip,
            api_key=api_key,
        )
  • Core helper function implementing the OpenFDA MAUDE device events search. Builds complex search queries, handles API requests, analyzes common problems, formats summaries and sample reports with genomics filtering.
    async def search_device_events(
        device: str | None = None,
        manufacturer: str | None = None,
        problem: str | None = None,
        product_code: str | None = None,
        genomics_only: bool = True,
        limit: int = OPENFDA_DEFAULT_LIMIT,
        skip: int = 0,
        api_key: str | None = None,
    ) -> str:
        """
        Search FDA device adverse event reports (MAUDE).
    
        Args:
            device: Device name to search for
            manufacturer: Manufacturer name
            problem: Device problem description
            product_code: FDA product code
            genomics_only: Filter to genomic/diagnostic devices only
            limit: Maximum number of results
            skip: Number of results to skip
            api_key: Optional OpenFDA API key (overrides OPENFDA_API_KEY env var)
    
        Returns:
            Formatted string with device event information
        """
        if not device and not manufacturer and not product_code and not problem:
            return (
                "⚠️ Please specify a device name, manufacturer, or problem to search.\n\n"
                "Examples:\n"
                "- Search by device: --device 'FoundationOne'\n"
                "- Search by manufacturer: --manufacturer 'Illumina'\n"
                "- Search by problem: --problem 'false positive'"
            )
    
        # Build and execute search
        search_query = _build_device_search_query(
            device, manufacturer, problem, product_code, genomics_only
        )
        params = {
            "search": search_query,
            "limit": min(limit, OPENFDA_MAX_LIMIT),
            "skip": skip,
        }
    
        response, error = await make_openfda_request(
            OPENFDA_DEVICE_EVENTS_URL, params, "openfda_device_events", api_key
        )
    
        if error:
            return f"⚠️ Error searching device events: {error}"
    
        if not response or not response.get("results"):
            return _format_no_results(device, manufacturer, problem, genomics_only)
    
        results = response["results"]
        total = (
            response.get("meta", {}).get("results", {}).get("total", len(results))
        )
    
        # Build output
        output = ["## FDA Device Adverse Event Reports\n"]
        output.extend(
            _format_search_summary(
                device, manufacturer, problem, genomics_only, total
            )
        )
    
        # Analyze and format problems
        all_problems, all_device_names, _ = analyze_device_problems(results)
        output.extend(format_top_problems(all_problems, results))
    
        # Show device distribution if searching by problem
        if problem:
            output.extend(format_device_distribution(all_device_names, results))
    
        # Display sample reports
        output.append(
            f"### Sample Reports (showing {min(len(results), 3)} of {total}):\n"
        )
        for i, result in enumerate(results[:3], 1):
            output.extend(format_device_report_summary(result, i))
    
        # Add tips
        if genomics_only:
            output.append(
                "\n💡 **Note**: Results filtered to genomic/diagnostic devices. "
                "Use --no-genomics-only to search all medical devices."
            )
    
        output.append(f"\n{OPENFDA_DISCLAIMER}")
        return "\n".join(output)
  • Exposes the search_device_events helper function for import in the MCP tool handler.
    from .device_events import (
        search_device_events,
        get_device_event,
    )
    from .drug_approvals import (
        search_drug_approvals,
        get_drug_approval,
    )
    from .drug_recalls import (
        search_drug_recalls,
        get_drug_recall,
    )
    from .drug_shortages import (
        search_drug_shortages,
        get_drug_shortage,
    )
    
    __all__ = [
        "get_adverse_event",
        "get_device_event",
        "get_drug_approval",
        "get_drug_label",
        "get_drug_recall",
        "get_drug_shortage",
        "search_adverse_events",
        "search_device_events",
        "search_drug_approvals",
        "search_drug_labels",
        "search_drug_recalls",
        "search_drug_shortages",
    ]
  • Helper function that constructs sophisticated OpenFDA search queries with exact matches, wildcards, multi-word handling, and genomic product code filtering.
    def _build_device_search_query(
        device: str | None,
        manufacturer: str | None,
        problem: str | None,
        product_code: str | None,
        genomics_only: bool,
    ) -> str:
        """Build the search query for device events."""
        search_parts = []
    
        if device:
            # Build flexible search queries
            device_queries = []
    
            # First try exact match
            device_queries.extend([
                f'device.brand_name:"{device}"',
                f'device.generic_name:"{device}"',
                f'device.openfda.device_name:"{device}"',
            ])
    
            # For multi-word terms, also search for key words with wildcards
            # This helps match "FoundationOne CDx" to "F1CDX" or similar variations
            words = device.split()
    
            # If it's a multi-word query, add wildcard searches for significant words
            for word in words:
                # Skip common words and very short ones
                if len(word) > 3 and word.lower() not in [
                    "test",
                    "system",
                    "device",
                ]:
                    # Use prefix wildcard for better performance
                    device_queries.append(f"device.brand_name:{word}*")
                    device_queries.append(f"device.generic_name:{word}*")
    
            # Also try searching by removing spaces (e.g., "Foundation One" -> "FoundationOne")
            if len(words) > 1:
                combined = "".join(words)
                device_queries.append(f'device.brand_name:"{combined}"')
                device_queries.append(f'device.generic_name:"{combined}"')
    
            search_parts.append(f"({' OR '.join(device_queries)})")
    
        if manufacturer:
            # Search manufacturer field with both exact and wildcard matching
            mfr_queries = [
                f'device.manufacturer_d_name:"{manufacturer}"',
                f"device.manufacturer_d_name:*{manufacturer}*",
            ]
            search_parts.append(f"({' OR '.join(mfr_queries)})")
    
        if problem:
            search_parts.append(f'device.device_problem_text:"{problem}"')
    
        if product_code:
            search_parts.append(f'device.openfda.product_code:"{product_code}"')
        elif (
            genomics_only and not device
        ):  # Only apply genomics filter if no specific device is named
            # Filter to genomic device product codes
            code_parts = [
                f'device.openfda.product_code:"{code}"'
                for code in GENOMIC_DEVICE_PRODUCT_CODES
            ]
            if code_parts:
                search_parts.append(f"({' OR '.join(code_parts)})")
    
        return " AND ".join(search_parts)

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