BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2133511 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02476
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PINION AXLE. ADDITIONAL INFORMATION: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 3RD. WHAT OTHER COLOUR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. 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)? HARD TO OPEN ONCE FIRED. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NOT ON THE LAST FIRING, THE HANDLE JAMMED. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED OPENED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. THE DEVICE OPENED AND CLOSED AS INTENDED. NO ADDITIONAL FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACH WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THERE WAS NO RELOAD RETURNED FOR ANALYSIS. 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 REVISION OF GASTRIC BYPASS PROCEDURE, A GOLD CARTRIDGE WAS LOADED AND FIRED TO PERFORM THE JEJUNO-JEJUNOSTOMY ANASTOMOSIS AND WHEN THE DEVICE WAS FIRED IT JAMMED. THE STAPLES WERE DELIVERED BUT DID NOT FORM CORRECTLY. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED FIVE MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4343F

    Patients

    Seq Age Sex Outcome Treatment
    1