BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOAD UNIT 60MM

    MDR report key: 2897164 · Received January 4, 2013

    Report

    Report Number
    3005075853-2013-00057
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN AN ATTEMPT TO FIRE WAS MADE, NO STAPLES DEPLOYED. THE DEVICE WAS EXAMINED AND THE STAPLE DRIVERS WERE EXPOSED. PROCEDURE WAS COMPLETED WITH SAME/LIKE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5219 PROXIMATE RELOAD UNIT 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1