BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LNR CUTR (UNK CODE)

    MDR report key: 2943980 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00482
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 16, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL AORTA ANEURYSM PROCEDURE, THE DEVICE WAS USED TO STAPLE OFF THE ANEURYSM. THE STAPLES DID NOT FORM. THE DEVICE WAS RELOADED WITH ANOTHER WHITE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT. THERE WAS NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48625 ENDOSCOPIC LNR CUTR (UNK CODE) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA AKSU

    Patients

    Seq Age Sex Outcome Treatment
    1