BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1820176 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07173
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    July 30, 2007
    Report Date
    July 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND THE NOSE CONE CRACKED. 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. 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 DURING A HYSTERECTOMY, THE HANDPIECE WAS PRODUCING SOLID TONES. THE CUSTOMER WAS ABLE TO CONTINUE USE OF THE DEVICE FOR THE CASE. THERE WAS 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