BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SISO II BULLET NOSE DISSECTING FORCEPS

    MDR report key: 1230444 · Received November 7, 2008

    Report

    Report Number
    9680400-2008-00001
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ACMI CANADA, INC.
    Product Code
    HCZ
    PMA / PMN Number
    K914883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO US TO COMPLETE THE INVESTIGATION. HOWEVER, ACCORDING TO THE INFO WE WERE ABLE TO GET FROM THE HOSPITAL, THE FORCEPS HAS NOT BEEN CLEANED AND STERILIZED ACCORDING TO THE PROCEDURE DESCRIBED IN THE IFU. IF FURTHER INFO BECOMES AVAILABLE OR THE DEVICE IS RECEIVED, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE BLUE COLORED PROTECTION PIECE ON THE DISSECTING FORCEPS FELL INTO THE PT. THE FORCEPS WERE INTACT WHEN IT WAS INSERTED INTO THE BODY AND WHEN IT WAS REMOVED, THE BLUE COLORED FRAME PIECE WAS MISSING. THE PIECE WAS RETRIEVED FROM THE PT, AND THE PT WAS FINE, RELEASED AS SCHEDULED AND IS AWARE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SISO II BULLET NOSE DISSECTING FORCEPS SISO II BULLET NOSE DISSECTING FORCEPS HCZ ACMI CANADA, INC. LA2-5273

    Patients

    Seq Age Sex Outcome Treatment
    1