BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3090322 · Received May 2, 2013

    Report

    Report Number
    3005075853-2013-02111
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 9, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION PROVIDED: WHAT LOCATION ON THE TISSUE? SIGMOID. ON WHICH FIRING(S) DID THIS EVENT OCCUR? 1ST. WHERE IN THE GREEN ZONE WAS THE DEVICE FIRED? YES. WAS BUTTRESSING MATERIAL UTILIZED? NO. WERE ANY DIFFICULTIES ENCOUNTERED WHEN CLOSING ON THE TISSUE? NO. WAS THE TISSUE PIN IN PLACE PRIOR TO FIRING? YES. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WAS ANOTHER STAPLING DEVICE USED DURING THIS SURGICAL PROCEDURE? CONTOUR. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. WAS PROXIMAL AND DISTAL CONTROL MAINTAINED ON THE TISSUE DURING THE FIRING SEQUENCE? YES. WAS THE STAPLE LINE INSPECTED FOR INTEGRITY PRIOR TO TRANSECTING THE TISSUE? YES. WHAT WERE THE QUALITY AND/OR THICKNESS OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? ASKU. WAS A LEAK TEST COMPLETED? NO. DID THE SURGEON WAIT 15 SECONDS AFTER CLAMPING AND PRIOR TO FIRING FOR OPTIMAL COMPRESSION? YES. WAS THE FIRING TO CLOSE A SIDE BY SIDE ANASTOMOSIS? NO.

    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 RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLECTOMY PROCEDURE THE SURGEON FIRED THE DEVICE AND WHEN HE REVIEWED THE STAPLE LINE IT WAS INCOMPLETE AND THE STAPLES WERE MALFORMED. THEY USED A CONTOUR DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ON WHAT TISSUE TYPE WAS THE DEVICE USED? COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192085 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4PM5R

    Patients

    Seq Age Sex Outcome Treatment
    1