BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HANDPIECE

    MDR report key: 1182484 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03645
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/11/2008. THE HANDPIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED. HOWEVER, THE HANDPIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. ADDITIONALLY, THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE COATING MATERIAL OF THE HOUSING FLAKING OFF. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE OF THIS CONDITION. PRELIMINARY EVALUATION REVEALED THAT THE LOOSE PARTICLES ON THE SURGACE ARE ALUMINUM OXIDE FROM THE BASE MATERIAL AFTER IT HAS CORRODED FROM MULTIPLE STERILIZATIONS. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNK PROCEDURE, THE CODE ERROR 5 OCCURRED. ANOTHER INSTRUMENT WAS USED AND THE SAME ERROR OCCURRED AGAIN. AFTER TESTING THE HANDPIECE, THE ERROR CODE 3 OCCURRED ALSO. NO PT CONSEQUENCES. A COMPETITOR DEVICE WAS USED TO START THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HANDPIECE NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR