BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 295106 · Received September 8, 2000

    Report

    Report Number
    MW1019866
    Event Type
    Injury
    Date Received
    September 8, 2000
    Date of Event
    July 11, 2000
    Report Date
    September 8, 2000
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT BROKE DURING THE CASE. ALL PORTIONS OF INSTRUMENT RETRIEVED. X-RAY TAKEN. (INSTRUMENT USED DURING LAPAROSCOPY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY IRRIGATOR (5MM FLOW SPATULA) KOG STRYKER ENDOSCOPY 250-070-441 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention