BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PADDLE RETRACT 12MM INSTRUMENT

    MDR report key: 3761329 · Received January 2, 2014

    Report

    Report Number
    2647580-2014-00007
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    November 18, 2013
    Report Date
    December 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAD
    PMA / PMN Number
    K914190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP NISSEN. ACCORDING TO THE REPORTER: MATERIAL FROM THE RETRACTOR LEFT FUZZY MATERIAL INSIDE THE PATIENT. NOTICED BY THE SURGEON AND PIECES WERE REMOVED. NO TISSUE LOSS. NO TISSUE DAMAGE. NO EXTENSION OF THE INCISION. NO BLOOD LOSS GREATER THAN 500CC. NO DELAY IN SURGICAL TIME OVER 30 MINUTES. NO DEVICE FRAGMENT FELL INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251 ENDO PADDLE RETRACT 12MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GAD COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3J0497X

    Patients

    Seq Age Sex Outcome Treatment
    1