BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE 54,55

    MDR report key: 727448 · Received June 19, 2006

    Report

    Report Number
    1527736-2006-02768
    Event Type
    Malfunction
    Date Received
    June 19, 2006
    Date of Event
    May 9, 2006
    Report Date
    May 11, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. IT WAS TESTED ON A GENERATOR AND A SOLID TONE WAS NOTED. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. 510(K) NUMBER IS K002906.

    Description of Event or Problem · 1

    THE DEVICE WAS SENT TO THE CALLER DUE TO NOT WORKING. NO FURTHER INFO AVAILABLE. NO PT CONSEQUENCE WAS REPORTED.

    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