BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PADDLE RETRACT 12MM INSTRUMENT

    MDR report key: 2915808 · Received December 6, 2012

    Report

    Report Number
    2647580-2012-00769
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    August 27, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GAD
    PMA / PMN Number
    K914190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: WHEN OPENING THE DEVICE, THE SOCK WAS OFF THE DEVICE AND NOT UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PADDLE RETRACT 12MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRU GAD COVIDIEN, FORMERLY USSC PUERTO RICO P1M1084X

    Patients

    Seq Age Sex Outcome Treatment
    1