BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60

    MDR report key: 3181846 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03186
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE EC60A DEVICE WAS RETURNED WITH THE CLOSING TRIGGER AND ANVIL IN CLOSED POSITION. THE DEVICE WAS NOTED TO BE LOADED WITH A 45MM CARTRIDGE RELOAD. IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60MM IFU. WHEN ATTEMPTING TO FIRE A 45MM RELOAD ON A 60MM DEVICE THE DEVICE WILL LOCK OUT. AFTER FURTHER ANALYSIS THE KNIFE WAS NOTED TO BE BUCKLED AT THE ARTICULATION. THE PHYSICAL EVIDENCE FOUND IS CONSISTENT WITH ATTEMPTING TO OVERPOWER A LOCKED DEVICE DUE TO THE INCORRECT CARTRIDGE LOADED, RESULTING IN THE KNIFE BUCKLING AND JAMMING NOT BEING ABLE TO RETURN THE FIRING MECHANISM TO THE HOME POSITION CONSEQUENTIALLY NOT BEING ABLE TO OPEN THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? BOWEL. WAS IT USED ON THICK TISSUE? NO. 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¿? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND (ALTHOUGH NO STROKES TO FIRE WERE MADE, LOCK OUT OCCURRED WHEN THE CLOSING TRIGGER WAS DEPRESSED). DURING WHICH STROKE DID THE EVENT OCCUR? PRIOR TO ANY STROKE BEING MADE. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNK (TO CONFIRM WITH THE SURGEON). WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? N/A ¿ THE DEVICE WAS NOT FIRED AT ALL WHEN THE LOCK OUT OCCURRED. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNK (TO CONFIRM WITH SURGEON). AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? AFTER 1ST FIRING YES, BUT NOT ONCE THE LOCK OUT OCCURRED. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES ¿ THE DEVICE HAD TO BE CUT OUT OF THE PATIENT WITH TISSUE STILL IN THE JAWS. THE DEVICE HAS BEEN SENT BACK FOR TESTING WITH TISSUE STILL IN THE JAWS. WAS THE DEVICE FULLY ARTICULATED? DEGREE OF ARTICULATION? YES THE DEVICE WAS ARTICULATED, THE DEGREE IS UNKNOWN, PRODUCT WAS WRAPPED UP WHEN I RECEIVED IT AND I DIDN¿T TAKE IT OUT OF THE BAG, HOWEVER THE DEVICE HAS BEEN SENT BACK STILL ARTICULATED AS THE USER COULD RETURN IT TO 0 DEGREES, SO THE TEAM TESTING SHOULD BE ABLE TO ANSWER THIS. HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM, OR WAS THIS TISSUE INTENDED TO BE CUT AWAY ANYWAY? YES ¿ EXTRA CUTS HAD TO BE MADE ON EITHER SIDE OF THE TISSUES INTENDED TO BE REMOVED. THE AMOUNT IN CM IS UNKNOWN HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? SURGERY WAS EXTENDED BY 45MINUTES, THE PATIENT WAS OK POST OPERATIVELY. WHAT TROUBLESHOOTING STEPS WERE TAKEN TO OPEN THE DEVICE? AS EXPLAINED PREVIOUSLY, THE TEAM FOLLOWED THE USUAL STEPS TO UNLOCK THE DEVICE, (REVERSING THE KNIFE BLADE, FIRING THE DEVICE ONCE TO OPEN), THEY TRIED PRISING THE TRIGGERS OPEN, FIRING REPEATEDLY, HIT THE OPEN BUTTON ETC. HOW LONG HAS THE SURGEON BEEN USING THE DEVICE? NOT SURE EXACTLY, BUT A NUMBER OF YEARS, HE IS NOT A NEW USER. HAS THE SURGEON BEEN INSERVICED? YES ¿ WOULD HAVE BEEN INSERVICED WHEN FIRST STARTED USING THE DEVICE. WAS THE DEVICE FIRED OVER OR NEAR ANY CLIPS OR OTHER HARD OBJECTS? NOT THAT I KNOW OF, ONE STAPLE LINE HAD ALREADY BEEN FIRED, SO IT WOULD HAVE BEEN CLOSE TO THAT. WAS THE DEVICE OPENED OR IS IT STILL IN CLOSED POSITION? SENT TO THE STATES STILL IN THE CLOSED POSITION, STILL ARTICULATED, STILL INSIDE THE TROCAR WITH TISSUE IN THE JAWS. WAS THE INCISION EXTENDED LARGER THAN WHAT WOULD HAVE BEEN BASED ON THE REMOVAL OF THE SPECIMEN? UNK ¿ WILL HAVE TO CHECK WITH SURGEON ON HIS RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PANPROCTOCOLECTOMY PROCEDURE, THE DEVICE 'LOCKED' OUT DURING THE SECOND FIRING. REVERSING THE KNIFE BLADE AND FIRING DID NOT WORK. THE DEVICE REMAINED LOCKED ON THE TISSUE. THE PATIENT HAD TO BE OPENED UP TO REMOVE THE DEVICE. A TX GUN WAS USED TO COMPLETE THE STAPLING. NO ILL EFFECTS SUFFERED BY PATIENT, AS HAD TO BE OPENED TO REMOVE THE SPECIMEN ANYWAY. NO CLEAR REASON FOR THE INABILITY TO OPEN THE JAWS. THE PROCEDURE WAS CONVERTED TO OPEN. SURGERY WAS PROLONGED FORTY-FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282860 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention