BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTO-LOK HUNTER GRASPER 3.5 X 24

    MDR report key: 1950091 · Received December 7, 2010

    Report

    Report Number
    2523190-2010-00018
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    December 7, 2010
    Product Code
    EXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE JAW BROKE DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE GRASPING A HARD GALLBLADDER. IT APPEARED TO THE CUSTOMER THAT NO PARTS WERE DETACHED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTO-LOK HUNTER GRASPER 3.5 X 24 NONE EXX

    Patients

    Seq Age Sex Outcome Treatment
    1