BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1911556 · Received November 17, 2010

    Report

    Report Number
    1911556
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MINI LAP TECHNOLOGIES INC STRYKER
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE TIPS OF THE GRASPER BROKE OFF IN THE PATIENT'S ABDOMEN AND WAS RETRIEVED BY THE SURGEON AFTER MAKING A FEW ADDITIONAL INCISIONS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DEVICE BROKE.====================== MANUFACTURER RESPONSE FOR MINILAP ALLIGATOR GRASPER, (BRAND NOT PROVIDED)======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MINILAP ALLIGATOR GRASPER GCJ MINI LAP TECHNOLOGIES INC STRYKER * ML-000086

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR