BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO DISSECT* 5MM INSTRUMENT

    MDR report key: 4161580 · Received July 23, 2014

    Report

    Report Number
    2647580-2014-00562
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GET
    PMA / PMN Number
    K904578
    Adverse Event
    Yes
    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: UNK. ACCORDING TO THE REPORTER: DURING PREPARATION , A NURSE NOTICED THE TIP OF DEVICE WAS BENT. A NEW DEVICE WAS OPENED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT HARM. THERE WAS NO DELAY IN OR TIME OF OVER 30 MINUTES. THERE WAS NO DAMAGE FOUND ON THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431025 ENDO DISSECT* 5MM INSTRUMENT DISPOSABLE SURGICAL STAPLER GET COVIDIEN, FORMERLY USSC P1M0566X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other