BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPERS

    MDR report key: 2231680 · Received August 26, 2011

    Report

    Report Number
    2231680
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    June 2, 2011
    Report Date
    August 26, 2011
    Manufacturer
    DAVIS AND GECK A SUBSIDIARY OF COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DAVIS AND GECK GRASPER BROKE WHILE IN THE PATIENT'S ABDOMEN. SURGEON USED ANOTHER GRASPER AND REMOVED ALL PIECES. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASPERS LAPAROSCOPIC GRASPER GCJ DAVIS AND GECK A SUBSIDIARY OF COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR