BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1782118 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00840
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE HAND PIECE WAS TESTED AND WAS FOUND TO FUNCTION PROPERLY. THE HAND PIECE WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. 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

    IT WAS REPORTED THAT DURING CALIBRATION FOR THE GENERATOR, THERE WAS AN ERROR CODE 4. 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