BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1823916 · Received January 16, 2008

    Report

    Report Number
    1527736-2008-00310
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 19, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL 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 INSTRUMENT NO LONGER MEETS THE SPECIFICATION FOR CONTINUITY. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE HANDPIECE DOES NOT WORK. NO OTHER INFO AVAILABLE. 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| HANDPIECE