BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO SHEARS 5MM INSTRUMENT

    MDR report key: 2760240 · Received September 20, 2012

    Report

    Report Number
    2647580-2012-00580
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 29, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GEI
    PMA / PMN Number
    K951589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE JAW MECHANISM WAS DAMAGED. THE CLOSURE IS MADE DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO SHEARS 5MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRU GEI COVIDIEN, FORMERLY USSC P1D1325

    Patients

    Seq Age Sex Outcome Treatment
    1