BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1121909 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01167
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 9, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND THE NOSE CONE CRACKED. IT WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED; IT ACTIVATED PROPERLY. HOWEVER, THE HAND PIECE NO LONGER MEETS THE DESIGN SPECIFICATIONS FOR CONTINUITY. THE HAND PIECE WAS DISASSEMBLED AND A TORN ACOUSTIC ISOLATOR WAS FOUND. 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 DURING A GYN PROCEDURE, THE DEVICE WOULD NOT ACTIVATE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR