BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX HOOK PROBE LONG

    MDR report key: 2760399 · Received September 18, 2012

    Report

    Report Number
    1219930-2012-00768
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: WHILE USING FOR AN ABRASION, THE TIP OF THE BLADE WAS BROKEN. THE BROKEN BLADE WAS RETRIEVED FROM THE CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX HOOK PROBE LONG DISPOSABLE SURGICAL DEVICE LFL COVIDIEN, FORMERLY US N2E0030X

    Patients

    Seq Age Sex Outcome Treatment
    1