BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 2600572 · Received June 1, 2012

    Report

    Report Number
    1219930-2012-00480
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: ON FRIDAY DURING DR. (B)(6) LAP CHOLE, THE BOTTOM JAW OF THE AUTOSONIX BROKE OFF AND WE WERE UNSUCCESSFUL AT RETRIEVING IT. WE USED A FLAT PLATE X-RAY AND C-ARM TO TRY TO LOCATE IT. WE COULD SEE IT BUT COULD NOT FIND IT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT DISPOSABLE SURGICAL DEVICE LFL COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other