BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 2915801 · Received December 6, 2012

    Report

    Report Number
    1219930-2012-00944
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING PRE-TESTING, THE SCRUB NURSE FOUND THAT THE SHEARS COULD NOT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG DISPOSABLE SURGICAL DEVICE LFL COVIDIEN LP, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1