BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1915522 · Received February 2, 2008

    Report

    Report Number
    1527736-2008-00633
    Event Type
    Malfunction
    Date Received
    February 2, 2008
    Date of Event
    August 7, 2007
    Report Date
    August 7, 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
    FR
    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. DURING FUNCTIONAL TESTING, A HISSING SOUND WAS NOTED DURING ACTIVATION WITH THE (B)(4). 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 AN UNKNOWN CASE, THE HAND PIECE DID NOT WORK. NO ERROR CODE ON THE GENERATOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT 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