BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS COMPACT ARTICNG

    MDR report key: 2872296 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05694
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 29, 2012
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? SMALL INTESTINE - JEJUNAL LOOP. ENTIRE THICKNESS. WAS IT USED ON THICK TISSUE? STANDARD THICKNESS. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? HE THINKS SO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 1ST AND ONLY. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? N/A. 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. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? CARDIA CANCER. PLEASE PROVIDE THE PATIENT'S SEX, AGE AND WEIGHT. FEMALE, (B)(6). WHAT IS THE CURRENT STATUS OF THE PATIENT? SHE'S IN GOOD HEALTH CONDITION. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE DEVICE USUALLY WORKS PROPERLY. NOT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED 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, CUT AND FORMED THE STAPLES AS INTENDED. THE CARTRIDGE WAS TAKEN OFF OF THE DEVICE AND PLACED BACK ON AND IT CLICK INTO PLACE. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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 A TOTAL GASTRECTOMY PROCEDURE, WHILE PERFORMING THE ROUX-EN-Y RECONSTRUCTION, MOST OF THE STAPLES APPLIED BY THIS STAPLER WERE OPEN. THE SURGEON NOTICED THIS UPON REOPENING THE STAPLER. THE CASE WAS CARRIED OUT AND FINISHED BY USING A NEW STAPLER. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS COMPACT ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4AP22

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR RELOAD-6R45B