BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54, 55

    MDR report key: 725891 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02587
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Date of Event
    April 11, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND NO ERROR CODES WERE FOUND. NO TEMPERATURE ISSUES WERE FOUND. THE HAND PIECE WAS DISASSEMBLED, A TORN ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. (510(K)#K002906)

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE, THE HAND PIECE OVER HEATED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR