BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 1940406 · Received December 9, 2010

    Report

    Report Number
    1219930-2010-00933
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    November 17, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: DURING THE CASE, THE TIP BROKE OFF. THE TIP WAS RECOVERED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG DISPOSABLE SURGICAL ACCESSORY LFL UNITED STATES SURGICAL N0G0647

    Patients

    Seq Age Sex Outcome Treatment
    1