BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST 33 CM, 5 MM CUTTING FORCEPS

    MDR report key: 1842423 · Received January 27, 2010

    Report

    Report Number
    2183680-2008-00021
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    May 30, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY. 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 REMOVAL OF THE UTERUS FROM THE CERVICAL STUMP, THE BLADE FRACTURED. IT WAS RECOVERED AND THE PIECES WERE REJOINED TO DETERMINE THAT NO PARTS WERE LEFT IN THE PATIENT. NO X-RAYS WERE TAKEN AND A COPIOUS AMOUNT OF IRRIGATION WAS PERFORMED. NO EVIDENCE OF RESIDUAL PIECES. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVEREST 33 CM, 5 MM CUTTING FORCEPS EVEREST BIPOLAR CUTTING FORCEPS GEI GYRUS MEDICAL, INC. 3006-020 8093010

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR