BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE STAPLER

    MDR report key: 3852995 · Received June 6, 2014

    Report

    Report Number
    3005075853-2014-03815
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 13, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE TRIGGER ADVANCED AND NO STAPLES DEPLOYED (WOULD NOT STAPLE)? DID THE DEVICE LOCKED OUT WITH NO STAPLES DEPLOYED (WOULD NOT FIRE)? RESPONSE FROM THE AFFILIATE: THE FIRING TRIGGER COULD STROKE, BUT COULD NOT STROKE P TO P (PLASTIC TO PLASTIC). NO STAPLE DEPLOYED. THE ANALYSIS RESULTS SHOWED THAT THE TX30G DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED WITH ONLY 14 STAPLES PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRING TRIGGER COULD NOT STROKE TO THE END. NO STAPLE DEPLOYED ON THE TISSUE. CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332814 PROXIMATE RELOADABLE STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DR9X

    Patients

    Seq Age Sex Outcome Treatment
    1