BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPAROSCOPIC TROCARE 2B5LT

    MDR report key: 4342317 · Received December 10, 2014

    Report

    Report Number
    MW5039614
    Event Type
    Other
    Date Received
    December 10, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 10, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC TROCAR NOTED TO HAVE CRACKS IN IT. THIS HAS PREVIOUSLY BEEN REPORTED TO MANUFACTURER STRYKER SUSTAINABILITY SOLUTIONS. MULTIPLE ITEMS OF SAME PRODUCT ON THE SHELF STILL IN PACK WERE NOTED TO HAVE CRACK AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797386 LAPAROSCOPIC TROCARE 2B5LT REMANUFACTURED TROCAR 5 MM GCJ STRYKER SUSTAINABILITY SOLUTIONS 2B5LT

    Patients

    Seq Age Sex Outcome Treatment
    1