BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLUS BLUNT GRASPER

    MDR report key: 824259 · Received February 16, 2007

    Report

    Report Number
    824259
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    December 10, 2006
    Report Date
    February 16, 2007
    Manufacturer
    ENDOPLUS INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ENDOPLUS BLUNT GRASPER BROKE WHILE INSIDE THE PATIENT. SURGEON REMOVED THE INSTRUMENT, INSPECTED THE SURGICAL FIELD WITH A CAMERA AND REMOVED A SMALL BLACK SPECK OF METAL. NO OTHER FOREIGN OBJECTS WERE NOTED WITH THE CAMERA. A CHOLANGIOGRAM WAS TAKEN AND NO FOREIGN OBJECTS WERE VIEWED ON X-RAY. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OP DAY THREE. BROKEN DEVICE AND THE METAL SPECK WERE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLUS BLUNT GRASPER GRASPER, SURGICAL GCJ ENDOPLUS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR