BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM

    MDR report key: 2222743 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03510
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 4, 2011
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011: WERE THERE NO STAPLES PRESENT AFTER THE FIRING? THERE WERE NO STAPLES VISIBLE AFTER THE FIRING; SURGEON CLAIMED THAT THERE WERE NO STAPLES IN THE RELOAD AT ALL. WERE THERE ANY PATIENT CONSEQUENCES DUE TO THE EVENT? NO PATIENT CONSEQUENCES REPORTED OTHER THAT THEY HAD TO MANUAL SUTURE THE LUNG AFTER THE STAPLES WERE NOT PLACED AND THE LUNG WAS MANUALLY RESECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SEGMENTAL LUNG RESECTION PROCEDURE, THE STAPLER WAS FIRED WITH ORIGINAL RELOAD, AND HELD CLOSED WHILE MANUAL RESECTION TOOK PLACE WITH A SCALPEL. AFTER THE DEVICE WAS OPENED, IT BECAME APPARENT THAT THE DEVICE HAD NOT FIRED. THE SURGEON DID NOT NOTICE ANYTHING BEFOREHAND THAT MAY HAVE INDICATED A PRODUCT FAULT AND CANNOT GIVE AN EXPLANATION FOR THE SITUATION. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 15 MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43D5X

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD PRODUCT # XR30B