BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2212561 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03319
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). KNIFE, CLOSURE TRIGGER TOP. THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED WITH THE KNIFE JAMMED AND WITH AN ECR60G CARTRIDGE RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE CLOSURE TRIGGER TOP WAS NOTED TO BE DAMAGE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. IN ADDITION, A CLIP WAS FOUND JAMMED BEHIND THE KNIFE, RESULTING IN THE FIRING MECHANISMS JAMMING NOT PERMITTING THE KNIFE TO RETURN TO THE HOME POSITION AND NOT ALLOWING THE DEVICE TO OPEN. TO MITIGATE THE POTENTIAL FOR HARD OBJECTS GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH POTENTIALLY JAMMING THE MECHANISM AND DAMAGING THE KNIFE EDGE DURING DEVICE FIRING PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION; THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A GASTRIC BYPASS SLEEVE. DURING THE 1ST FIRING ACROSS THE PYLORUS, AFTER SECOND STROKE, THE SURGEON HAD TO USE TWO HANDS TO FIRE. THE DEVICE WAS STUCK ON THE TISSUE AND WOULD NOT OPEN. THE SURGEON PUSHED THE RELEASE BUTTON AND IT STILL DID NOT OPEN. THE DEVICE WAS FINALLY FORCED OPEN BY USING THE RELEASE BUTTON AND PULLING THE CLOSING TRIGGER FORWARD. THE CLOSING TRIGGER BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? PYLORUS AT WHAT LOCATION ON THE TISSUE? PYLORIC ANTRUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. DURING WHICH STROKE DID THE EVENT OCCUR? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO. WAS BUTTRESSING MATERIAL UTILIZED? NO IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? NA. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? FIRING TRIGGER AT END OF FIRING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THICK TISSUE OF STOMACH. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? MORBID OBESITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43G8L

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G