BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 65198 · Received December 31, 1996

    Report

    Report Number
    65198
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    July 10, 1996
    Report Date
    July 10, 1996
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN USING A 4-0 ROUND BURR IN THE SHOULDER, THE BURR PORTION GROUND AGAINST THE HOOD CAUSING PARTICLES OF METAL TO FLAKE OFF IN THE PT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY 4.0 ROUND BURR HTT STRYKER ENDOSCOPY 275-841-000 96035452

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention