BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1820120 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07191
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Report Date
    April 4, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED IN GOOD CONDITION. THE ANALYSIS WAS PERFORMED AND WAS FOUND THAT THE HAND PIECE NO LONGER MEETS THE SPECIFICATIONS FOR IMPEDANCE, PHASE MARGIN. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED BUT WITHOUT ANY INFORMATION. NO FURTHER INFORMATION REGARDING THIS DEVICE IS AVAILABLE.

    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