BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080332 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00295
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    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

    DATE SENT: 07/08/2008. THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND NO ERROR CODES WERE NOTED. THE INSTRUMENT NO LONGER MEETS DESIGN SPECIFICATIONS FOR PHASE MARGIN. FOR FURTHER ANALYSIS, THE HAND PIECE WAS DISASSEMBLED AND A TORN ACOUSTIC ISOLATER WAS FOUND INSIDE. DUE TO THIS CONDITION, MAY LEAD TO OCCUR ACTIVATION ISSUES OR INCOMPLETE INITIAL TEST. 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, THE HAND PIECE DID NOT PASS THE PRE RUN TEST. THE CASE WAS COMPLETED BY USING ANOTHER HANDPIECE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE NONE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR