BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 3835682 · Received May 21, 2014

    Report

    Report Number
    MW5036269
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKING OCCURRED FROM CLEAR TUBE AT AREA OF BATTERY PACK. DIAGNOSIS OR REASON FOR USE: OPEN APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303030 STRYKER ENDOSCOPY STRYKERFLOW II SUCTION/IRRIGATOR GCX STRYKER 250-070-500 14080FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR