BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080331 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00294
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/08/2008. THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND THE NOSE CONE CRACKED. THE ANALYSIS WAS PERFORMED AND WAS FOUND THAT THE HAND PIECE NO LONGER MEETS THE SPECIFICATIONS FOR CONTINUITY. IT WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED. THE HAND PIECE WAS DISASSEMBLED AND FOUND A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS INSIDE OF IT. COMPLAINT INFO IS TRENDED ON A REGUALR 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 LAP GASTRIC BYPASS PROCEDURE, THE HANDPIECE HOUSING WAS CRACKED. ANOTHER DISPOSABLE HAD TO BE PULLED. THERE WAS NO PT CONSEQUENCE.

    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