BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 391918 · Received April 25, 2002

    Report

    Report Number
    MW1024874
    Event Type
    Malfunction
    Date Received
    April 25, 2002
    Date of Event
    April 24, 2002
    Report Date
    April 25, 2002
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR WAS USING A STRYKER ENDOSCOPY SUCTION/IRRIGATOR DURING A LAPAROSCOPIC CHOLECYSTECTOMY. NORMAL SALINE SOLUTION WAS USED DURING THE PROCEDURE. AT END OF PROCEDURE WHEN NURSE TOOK SPIKE FROM IRRIGATION AND SUCTION BAG, IT WAS NOTED BLACK FLUID COMING OUT OF BATTERY CASE. POURED 45 CC'S OF BLACK FLUID. BATTERY WAS WARM AND WAS HISSING. UNIT WAS ISOLATED IN A BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY SUCTION IRRIGATOR KOG STRYKER ENDOSCOPY 536571-01 02035232

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other