BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 1932790 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07255
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE B): G5ZF94 (BATCH #); EXP DATE = 05/04/2015. (DEVICE B): 6/4/2010. (DEVICE C): G5062T (BATCH #); EXP DATE = 07/05/2015. (DEVICE C): 8/5/2010. DEVICES (A), (B) AND (C) WERE RETURNED IN GOOD VISUAL CONDITION AND WITH FULLY FIRED CARTRIDGE RELOADS LOADED ON THE DEVICES. THE DEVICES WERE TESTED FOR FUNCTIONALITY WITH TEST CARTRIDGE RELOADS AND THE DEVICES ACHIEVED THEIR COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINES AND CUT LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICES PERFORMED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPARATOMY, THE DEVICE FIRED MALFORMED STAPLES. A NEW DEVICE WAS USED TO COMPLETE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE