BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 203508 · Received December 22, 1998

    Report

    Report Number
    MW1015293
    Event Type
    Malfunction
    Date Received
    December 22, 1998
    Date of Event
    December 8, 1998
    Report Date
    December 15, 1998
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER USING STRYKER ENDOSCOPIC SHAVER, PHYSICIAN NOTED WHAT APPEARED TO BE VERY FINE METAL SHAVINGS IN THE KNEE JOINTS. KNEE JOINT WAS IRRIGATED PROFUSELY WITH SALINE. NO OBVIOUS DEFECT NOTED TO SHAVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY ARTHROSCOPIC SHAVER BLADE HRX STRYKER ENDOSCOPY UNK 98075792

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other