BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER LAPAROSCOPIC ATRAUMATIC GRASPER

    MDR report key: 21124901 · Received January 9, 2025

    Report

    Report Number
    MW5164534
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 7, 2025
    Manufacturer
    STRYKER LEIBINGER GMBH & CO. KG
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT CHOLECYSTECTOMY. A SURGICAL INSTRUMENT, A STRYKER 250-080-767 LAPAROSCOPIC ATRAUMATIC GRASPER, WAS USED. AFTER USE, STAFF RECOGNIZED THAT THE GRASPING PART LOOKED UNUSUAL. THEY SENT IT DOWN TO STERILE PROCESSING WHO DETERMINED THAT THERE WAS A TINY PIN MISSING FROM THE MOVING PART SECTION OF THE GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656531 STRYKER LAPAROSCOPIC ATRAUMATIC GRASPER FORCEPS, GENERAL & PLASTIC SURGERY GEN STRYKER LEIBINGER GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other