BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 2568492 · Received May 4, 2012

    Report

    Report Number
    2183680-2012-00024
    Event Type
    Injury
    Date Received
    May 4, 2012
    Date of Event
    April 6, 2012
    Report Date
    April 6, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 COLLAR DETACHED AND FELL INTO THE PT. THE SURGEON RETRIEVED THE PIECE FROM THE PT, WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS MEDICAL INC. 3005PK 394828MD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK