BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS DISSECTOR FORCEPS

    MDR report key: 1900545 · Received October 29, 2010

    Report

    Report Number
    2183680-2010-00049
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    GYRUIS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED. THE DEVICE WAS RETURNED WITH A FRACTURED HUB, THE HUB FRACTURED UNDER THE HEAT SHRINK TUBING BEHIND THE CENTER PIVOT RIVET. THE FRACTURE OCCURRED AT THE THIN TRANSITION SECTION OF THE HUB, ALSO OBSERVED IS THE PIVOT ROD END AT THE PIVOT LINK IS BENT SLIGHTLY UPWARDS WHICH WOULD INDICATE A LATERAL LOAD OR FORCE BEING APPLIED TO THE DISTAL END OF THE DEVICE. PLACED THE FRACTURED PARTS TOGETHER AND ALL PARTS ARE ACCOUNTED FOR. FAILURES SUCH AS THESE HAVE BEEN ATTRIBUTED TO EXCESSIVE FORCE BEING APPLIED TO THE DEVICE BEYOND ITS DESIGNED SPECIFICATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE TIP OF THE DISSECTOR BROKE IN THE ABDOMEN. THE TIP DID NOT BREAK COMPLETELY OFF. THERE WAS NO PT INJURY. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS DISSECTOR FORCEPS DISSECTING FORCEPS GEI GYRUIS MEDICAL, INC. 942005PK 204449HC

    Patients

    Seq Age Sex Outcome Treatment
    1