BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1820180 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07166
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 1, 2007
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED. HOWEVER, A HISSING SOUND WAS HEARD. THE HAND PIECE WAS DISASSEMBLED; A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. ADDITIONALLY, THE DEVICE NO LONGER MEETS THE SPECIFICATIONS FOR CONTINUITY. COMPLAINT INFORMATION 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SETTING UP FOR A GASTRIC BYPASS, RECEIVED ERROR CODE 3. REPLACED THE HANDPIECE AND COMPLETED THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR