BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAHE MEDIZ INTERHNIK

    MDR report key: 117422 · Received June 27, 1997

    Report

    Report Number
    117422
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    April 15, 1997
    Report Date
    April 25, 1997
    Manufacturer
    MAHE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLEYCYSTECTOMY, UPON REACHING TO REMOVE THE GALLBLADDER, IT WAS NOTED THAT ONE OF THE GRASPERS HAD BROKEN OFF. A SUBCOSTAL INCISION WAS MADE TO RETRIEVE THE BROKEN OFF GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHE MEDIZ INTERHNIK MAXI-GRASPER GCJ MAHE 2102833 11/95

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention