BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1083051 · Received July 24, 2008

    Report

    Report Number
    1527736-2008-03881
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 17, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND THE NOSE CONE CRACKED. IT WAS TESTED ON A GENERATOR AND FOUND TO BE FUNCTIONAL. THE HAND PIECE WAS DISASSEMBLED AND A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS WERE 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS SET ASIDE BECAUSE OF AN UNKNOWN REASON. THERE WERE NO DETAILS AVAILABLE. THE REP TESTED THE HANDPIECE AND FOUND THE MOUNT WAS LOOSE.

    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