BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33CM PKS OMNI INSTRUMENT

    MDR report key: 1800140 · Received August 10, 2010

    Report

    Report Number
    2183680-2010-00040
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 10, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, THE HUB WAS FRACTURED UNDER THE SHRINK TUBING OF THE SHAFT. THE SHRINK TUBING WAS REMOVED TO EXPOSE THE HUB. THE FRACTURE CONSISTED OF TWO LARGE PIECES AND SEVERAL SMALL FRAGMENTS. BREAKAGE OCCURRED AT THE DISTAL END OF THE SHAFT. DAMAGE TO THE ELECTRICAL WIRES WAS FOUND AND APPEARS TO BE RELATED TO THE FRACTURE OF THE HUB. SEVERAL SMALL FRAGMENTS WERE FOUND IMBEDDED IN THE SHAFT SHRINK TUBING. WHEN COMPARED TO AN INTACT HUB, WE CANNOT VERIFY THAT ALL OF THE FRAGMENTS ARE ACCOUNTED FOR. THERE WAS NO REPORTED PT HARM AND THE HUB FRACTURE OCCURRED IN A LOCATION UNDER THE SHRINK TUBING WHICH MAY HAVE PREVENTED THE FRAGMENTS FROM ESCAPING INTO THE BODY. THE EXTENT OF THE HUB FRACTURE COULD NOT BE DETECTED UNLESS THE SHRINK TUBING WAS REMOVED. CARDIFF, UK'S R&D TEAM HAS BEEN WORKING ON A HUB REDESIGN WHICH WILL ADDRESS THIS HUB FRACTURING ISSUE. THIS REDESIGN HAS NOT YET BEEN IMPLEMENTED TO DATE. HUB FRACTURES HAVE BEEN ATTRIBUTED TO EXCESSIVE FORCE BEING APPLIED TO THE DEVICE BEYOND ITS DESIGNED SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE HUB ON THE PKS OMNI INSTRUMENT FRACTURED AND THE JAWS WOULD NOT OPERATE. THE DEVICE WAS REMOVED FROM THE OPERATING SITE AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM PKS OMNI INSTRUMENT PKS OMNI INSTRUMENT, 33CM GEI GYRUS MEDICAL, INC. 970010PC 143956MB

    Patients

    Seq Age Sex Outcome Treatment
    1