BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3102972 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02206
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? POUCH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 3RD. WHAT COLOR CARTRIDGE WAS BEING USED? 6R45M. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE ON 1ST FIRE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH FOUR RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED PROPERLY DURING TESTING. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, ON THE THIRD FIRING ON THE POUCH THE STAPLES WERE MALFORMED. THEY WERE IN AN INVERTED "B" SHAPE. UPON EXAMINATION OF THE STAPLE LINE, THERE WERE NO LEAKS OR BLEEDING. THIS WAS ON THE REMNANT SIDE OF THE POUCH. TO REINFORCE THE AREA, THE SURGEON WENT OVER THE AREA WITH A POWERED ECHELON. THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE ALONG WITH THE CARTRIDGES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203968 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CE72

    Patients

    Seq Age Sex Outcome Treatment
    1 6R45M, TR45W