BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX HOOK PROBE SHORT

    MDR report key: 3080701 · Received April 9, 2013

    Report

    Report Number
    1219930-2013-00231
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    COVIDIEN, FORMELRY US SUR
    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: BREAST RECONSTRUCTION. ACCORDING TO THE REPORTER: THE POWER TO THE HANDLE STOPPED AND A STRANGE LOUD SOUND WAS HEARD, THEN SUDDENLY THE TIP OF THE HOOK PROBE BROKE OFF. THE TIP FELL INTO THE PT CAVITY BUT WAS RETRIEVED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLOOD LOSS OF MORE THAN 250 CC. THERE WAS NO EXTENSION OF THE INCISION OF MORE THAN 1 INCH AND THERE WAS NO UNANTICIPATED OR IRREVERSIBLE DAMAGE TO THE VASCULAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148073 AUTOSONIX HOOK PROBE SHORT DISPOSABLE SURGICAL DEVICE LFL COVIDIEN, FORMELRY US SUR N2E0027X

    Patients

    Seq Age Sex Outcome Treatment
    1