BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER

    MDR report key: 3242399 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03677
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 28, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED WITH A TR35W CARTRIDGE LOADED ON THE DEVICE UNFIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED WITH A TR35W CARTRIDGE LOADED ON THE DEVICE UNFIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH # K59K4Y (MFG DATE 02.16.2013; EXP DATE 01.16.2018).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE PROCEDURE, THAT WITH THE USE OF TWO DEVICES, DESPITE THE CARTRIDGES BEING SEATED CORRECTLY AND APPEARED TO FIT PROPERLY, THE CARTRIDGES WERE RELEASING PRIOR TO BEING DEPLOYED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343383 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C520

    Patients

    Seq Age Sex Outcome Treatment
    1