BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*VASC LIN STAP RELOAD

    MDR report key: 4243846 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07842
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 10, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE XR30V RELOAD ARRIVED IN GOOD VISUAL CONDITION AND PARTIALLY LOADED WITH ONLY 5 STAPLES PRESENT AND ALL PROTRUDING. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITIONS OF THE RELOAD. IT SHOULD BE NOTED THAT WHEN MANIPULATING THE DEVICE ONLY THE CLOSING TRIGGER SHOULD BE GRASP UNTIL READY TO FIRE THE DEVICE. DO NOT GRASP THE FIRING TRIGGER BEFORE THE DEVICE IS TO BE FIRED. IF THE FIRING TRIGGER IS MANIPULATED IT COULD CAUSE THE STAPLES TO DEPLOY PARTIALLY OR COMPLETELY RESULTING IN MALFORMED STAPLES AND A PREMATURE LOCKOUT SITUATION. FOR FURTHER DETAILS PLEASE REFER TO THE INSTRUCTION FOR USE. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A VATS LUNG LOBECTOMY PROCEDURE, A RELOAD WAS ASSEMBLED WITH TX BY A SCRUB NURSE DURING THE SURGERY. IT WAS THE FIRST FIRING WITH THE TX. THE SURGEON WAS HANDED OVER THE TX WITH XR30V AND HE FOUND FIRST ROW OF ITS RELOAD IS POPPED UP. SO, HE DIDN'T USE IT AND THE SCRUB NURSE CHANGED ITS RELOAD TO ANOTHER ONE. HE FINISHED WITH ANOTHER XR30V WITH SAME TX. IT WAS FOUND BEFORE USING ON PATIENT, SO PATIENT IS OK. PROCEDURE WAS PROLONGED BY ONE MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726379 PROXIMATE*VASC LIN STAP RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C898

    Patients

    Seq Age Sex Outcome Treatment
    1