BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 4003130 · Received June 26, 2014

    Report

    Report Number
    2647580-2014-00482
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COVIDIEN FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAD
    PMA / PMN Number
    K914190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ACCORDING TO THE REPORTER: DURING RENAL DEPRESSION A BLACK PLASTIC PART AT THE PROXIMAL PART OF FIVE WINGS GOT BROKEN. THE BROKEN PARTS COULD BE RETRIEVED FROM PT OPERATING TIME NOT EXTENDED. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. NO PT HARM. ADDITIONAL TISSUE RESECTION: NO. TISSUE DAMAGE: NO. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373121 ENDO RETRACT II 10MM INSTRUMENT NONE GAD COVIDIEN FORMERLY USSC PUERTO RICO, INC. P3K0149X

    Patients

    Seq Age Sex Outcome Treatment
    1