BEUDAMED
    FDA Adverse Event Other Summary report: N

    DETACH INSERT HOOK SCISSORS

    MDR report key: 3448873 · Received September 21, 2005

    Report

    Report Number
    8010877-2005-00005
    Event Type
    Other
    Date Received
    September 21, 2005
    Report Date
    July 25, 2005
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMING A VISUAL INSPECTION WITH THE NAKED EYE, WE FOUND THAT A CLIP WAS STUCK IN BETWEEN THE SCISSOR BLADES. THE JAW HOLDER IS BENT OPEN AND THE PROXIMAL END OF THE DRAW BAR STRONGLY DEFORMED. IN AN EFFORT TO REPRODUCT THE DEVIATION DESCRIBED BY THE USER, WE WERE NOT SUCCESSFUL IN OPENING THE JAW WITH A CLIP - NOT EVEN WHEN THE INSTRUMENT WAS NOT JAMMED. SUBJECTING THE INSTRUMENT TO A VISUAL INSPECTION UNDER THE MICROSCOPE, WE FOUND THAT MATERIAL WAS SHORN OFF THE CLIP. A SHEARING OFF OF MATERIAL CAN HAPPEN WHEN SOMEONE TRIES TO CUT THE CLIP USING THE SCISSOR. DUE TO THE HARD MATERIAL THE CLIP CONSISTS OF, BOTH THE SCISSOR BLADES AND THE JAW HOLDER ARE BENT APART AND THE CLIP GETS STUCK. GIVEN THESE FACTS, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE NONCONFORMANCE DESCRIBED. SINCE THIS EVALUATION INDICATES NO DEFECT OF MATERIAL, NO DEFECT IN DESIGN OR ANY DEFECT IN MANUFACTURING, WE FEEL THAT NO CORRECTIVE MEASURE IS TO BE TAKEN.

    Description of Event or Problem · 1

    ACCORDING TO THE HOSPITAL, THE FOLLOWING OCCURRED DURING SURGERY; WHEN THE SURGEON TRIED TO CUT TISSUE WITH THE INSTRUMENT IN QUESTION, THE LATTER JAMMED AND WOULD NOT OPEN ANY MORE. USING A HEMOCLIP, THEY MANAGED TO OPEN THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DETACH INSERT HOOK SCISSORS DETACH INSERT HOOK SCISSORS LRW KOSCHER & WUERTZ GMBH 0044377

    Patients

    Seq Age Sex Outcome Treatment
    1