BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1820943 · Received October 29, 2007

    Report

    Report Number
    1527736-2007-07111
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 25, 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
    AZ, 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 GAVE A SOLID TONE. THE HAND PIECE WAS DISASSEMBLED; A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. ADDITIONALLY, THE CONTINUITY WAS OUT OF SPECIFICATION. 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 HANDPIECE HAD AN UNK PROBLEM. THERE WERE NO DETAILS AVAILABLE ON THE PROBLEM, BUT THERE WERE SOLID TONES WHEN ACTIVATING WITH A TEST TIP DURING TROUBLESHOOTING. THERE WAS NO PT CONSEQUENCE REPORTED.

    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