BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55

    MDR report key: 729208 · Received June 16, 2006

    Report

    Report Number
    1527736-2006-02741
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Report Date
    April 13, 2006
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6: TORN ACOUSTIC ISOLATOR. BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND A CRACKED NOSE CONE. THE ANALYSIS WAS PERFORMED AND WAS FOUND THAT THE HAND PIECE NO LONGER MEETS THE SPECIFICATIONS FOR CONTINUITY, FREQUENCY, AND PHASE MARGIN. THE HANDPIECE WAS TESTED ON A GENERATOR AND GAVE AN ERROR CODE 3. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. 510K#: K002906

    Description of Event or Problem · 1

    THE DEVICE WAS NOT WORKING. NO FURTHER INFORMATION AVAILABLE. NO PATIENT CONSEQUENCE OCCURRED. UNKNOWN HOW THE CASE WAS COMPLETED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55 LFL LFL ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR