BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 2922258 · Received January 11, 2013

    Report

    Report Number
    2183680-2013-00004
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE CUTTING FORCEPS BROKE AND FAILED. THE CASE WAS COMPLETED SWITCHED FROM PK CUTTING FORCEPS TO A LIGASURE INSTRUMENT. THE PT EXPERIENCED LONGER STAY THAN NORMAL, BUT NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17005 PKS CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS MEDICAL, INC. 3005PK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK