BEUDAMED
    FDA Adverse Event Summary report: N

    MULTIAPPLIER CLIP APPLIER W/ REUSE HANDLE

    MDR report key: 1122523 · Received August 14, 2008

    Report

    Report Number
    9615027-2008-00001
    Date Received
    August 14, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 28, 2008
    Manufacturer
    DEXIDE GERMANY
    Product Code
    GDO
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE JAWS OF THE CLIP APPLIERS LOCKED IN THE CLOSED POSITION. THERE WAS SOME TISSUE DAMAGE AND IT WAS CORRECTED USING NEW INSTRUMENTS OF DIFFERENT TYPES AND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF BLOOD LOSS, PIECES FALLING INTO THE CAVITY OR THE INCISION BEING EXTENDED AS A RESULT OF THE REPORTED NONCONFORMITY. HOWEVER, SURGERY TIME WAS EXTENDED THIRTY FIVE MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIAPPLIER CLIP APPLIER W/ REUSE HANDLE DISPOSABLE SURGICAL CLIP APPLIER GDO DEXIDE GERMANY 040033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention W/ REUSE HANDLE| MULTIAPPLIER CLIP APPLIER