BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE

    MDR report key: 17583714 · Received August 21, 2023

    Report

    Report Number
    17583714
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 20, 2023
    Manufacturer
    SILEX MEDICAL, LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRESTIGE LAP GRASPER BEING USED IN SURGERY, WHILE BEING USED INSIDE PATIENT, ONE OF THE JAWS OF THE GRASPER BROKE OFF. BROKEN PIECE WAS OBTAINED AND REMOVED FROM PATIENT. DEVICE SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410805 SIGNATURE LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ SILEX MEDICAL, LLC 5864000

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Unknown