BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX HOOK PROBE SHORT

    MDR report key: 3033330 · Received March 1, 2013

    Report

    Report Number
    1219930-2013-00137
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: MASTECTOMY. ACCORDING TO THE REPORTER: THE POWER TO THE HANDLE STOPPED AND A STRANGE LOUD SOUND WAS HEARD. SUDDENLY, THE TIP OF THE HOOK PROBE BROKE OFF. THERE WAS NO EXTENSION OF SURGERY TIME BY MORE THAN 30 MINUTES, NO BLOOD LOSS OF MORE THAN 250 CC, NO EXTENSION OF THE INCISION OF MORE THAN 1 INCH, NO UNANTICIPATED OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE. THE PIECE FELL INTO PT CAVITY BUT WAS RETRIEVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90246 AUTOSONIX HOOK PROBE SHORT DISPOSABLE SURGICAL DEVICE LFL COVIDIEN, FORMERLY US SURGICAL N2E0027X

    Patients

    Seq Age Sex Outcome Treatment
    1