BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1191004 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03572
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/09/2008. EVAL SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE HANDPIECE WAS RETURNED WITH THE 4-40 STUD BROKEN. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. HOWEVER, THE EVALUATION REVEALED THAT THE CAUSES THAT MAY CONTRIBUTE TO THIS ARE DROPPING OF THE INSTRUMENT, CROSS THREADING OF BLADE OR SHEAR, SIDE LOADING WITH BLADE ATTACHED, OVER TORQUE OR PLASTIC TORQUE WRENCH NOT USED. ADDITIONALLY, THE HANDPIECE WAS RETURNED WITH THE MOUNT LOOSE AND THE NOSE CONE CRACKED. THE HANDPIECE WAS DISASSEMBLED; A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4-40 STUD BROKE OFF WHILE ATTEMPTING TO CONNECT THE INSTRUMENT PRIOR TO THE UNK PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND HANDPIECE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR