BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 2554350 · Received May 1, 2012

    Report

    Report Number
    3005075853-2012-02042
    Event Type
    Death
    Date Received
    May 1, 2012
    Date of Event
    March 30, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS SHOWED THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH NO CARTRIDGE RELOAD PRESENT. NO CARTRIDGE RELOAD WAS RETURNED FOR ANALYSIS. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. PER EVENT DESCRIPTION IT IS POSSIBLE THAT THE RELOAD WAS NOT LOADED OR SEATED PROPERLY BEFORE THE FIRING SEQUENCE OF THE DEVICE. IF THE CARTRIDGE IS NOT FULLY INSERTED/SEATED INTO THE CHANNEL, THE RETENTION FEATURES ON THE CARTRIDGE ARE NOT ENGAGED TO THE CHANNEL WINDOWS OF THE DEVICE. AT FIRING THE DEVICE WILL PUSH THE CARTRIDGE FORWARD. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE WAS NOT PROPERLY SEATED BEFORE THE DEVICE WAS FIRED, IT IS POSSIBLE THAT WHILE MANIPULATING THE DEVICES INTO THE TISSUE TO BE STAPLED THE MOST DISTAL PART OF THE CARTRIDGE ENCOUNTERED AN UPWARD FORCE EITHER FROM CONTACT WITH ANOTHER DEVICE OR AN ORGAN RESULTING IN THE CARTRIDGE TO PARTIALLY DISENGAGING FROM THE CHANNEL. IT SHOULD BE NOTED THAT 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THAT THE CARTRIDGES ARE LOADED CORRECTLY.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL FOLLOW UP: PLEASE QUANTIFY THE AMOUNT OF BLOOD THE PATIENT LOST: 1200ML. WERE ANY STAPLES DISCHARGED FROM THE RELOAD CARTRIDGE? NO, THE CARTRIDGE SEEMS TO HAVE FELT INTO THE PATIENT AS THEY FOUND IT AFTER THE FIRE/FEEL IT'S UNUSUALLY EASY TO FIRE/SEE IT ONLY CUTS/OPEN THE PATIENT IN EMERGENCY/ REPAIR THE ARTERY WERE ANY STAPLES VISIBLE AFTER FIRING? IF YES, WHAT WAS THE STAPLE SHAPE - UNFORMED, MALFORMED? NO STAPLES ON THE ARTERY. PLEASE DESCRIBE WHAT STEPS WERE TAKEN TO REPAIR THE PULMONARY ARTERY. WHAT WAS THE CONDITION OF THE PATIENT FOLLOWING SURGERY - STABLE, DISCHARGED, CRITICAL - PLEASE EXPLAIN? CRITICAL. HE HAD OTHER CONDITIONS, AND DURING THE WEEK END HIS LEG WAS SO BAD THAT THEY AMPUTEE HIM. HAPPENED (B)(6), I WAS TOLD BY THE SURGEON THAT THE PATIENT IS NOT GOING TO SURVIVE. CONDITION UNK. ON WHAT TISSUE TYPE WAS THE DEVICE USED? PULMONARY ARTERY. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST. WHAT COLOUR CARTRIDGE WAS BEING USED? WHITE. WAS BUTTRESSING MATERIAL USED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR EXISTING STAPLE LINE(S) OR CLIP(S)? NO. WERE ANY UNEXPECTED NOISES HEARD? MORE A FEELING THAN A SOUND. IF SO, WHEN? WHEN FIRING, HE FELT IT WAS TOO EASY AND KNEW THERE WAS NO CARTRIDGE, BUT IT WAS TOO LATE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, OPENING OR FIRING)? YES. IF YES, PLEASE EXPLAIN: EASIER TO PUSH WHEN THERE IS NOT 6 STAPLE LINES TO FORM. 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 TISSUE? NO. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? YES. IF SO, WHAT? MANY CONDITIONS AS DIABETES TYPE 2, FEM POP BY PASS - HAS THE PATIENT RECENTLY HAD RADIATION OR CHEMOTHERAPY? UNK. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? 5 YEARS. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT /SURGEON? NO. RESPONSES TO QUESTIONS FROM REP: .WERE ANY STAPLES DISCHARGED FROM THE RELOAD THAT WAS FOUND IN THE PATIENT? NO. PLEASE DESCRIBE WHAT STEPS WERE TAKEN TO REPAIR THE PULMONARY ARTERY. THEY QUICKLY CONVERTED TO OPEN AND CLOSED THE ARTERY WITH A PROLENE SUTURE. WHAT WERE THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS? THERE WAS A LOT, HE HAD A CARDIAC SURGERY (B)(6), HE HAD A FEM POP BY PASS. HE WAS DIABETIC. THEY DISCOVERED HIS CANCER WAS AT AN ADVANCED STAGE AS HE HAD ATTACK HIS GANGLIONS. PLEASE DESCRIBE THE COMPLICATION WITH THE LEG AND REASON FOR AMPUTATION. THE PATIENT HAD A FEM POP BYPASS AND THEY PUT HIM COMPRESSION SOCKS FOR THE TIME OF THE SURGERY. THEY WERE THERE JUST IN CASE THEY NEEDED IT, THEY WERE NOT SUPPOSED TO START THEM RIGHT AWAY. UNFORTUNATELY, AT THE CHANGE OF SHIFT AT 4PM, THE NEW NURSE THOUGHT HER PREVIOUS COLLEAGUE FORGOT TO START THEM SO SHE WANTED TO COVER "THE MISTAKE" AND START THEM. THIS CAUSED COMPLICATIONS TO THE LEG OF THE PATIENT THAT HAD TO BE AMPUTATED THE FOLLOWING DAY. IF PROBLEMS WITH THE LEG WERE DUE TO AN ACCIDENT, PLEASE PROVIDE DATE AND DETAILS OF ACCIDENT. HAS THE PATIENT DIED? IF SO, ON WHAT DATE? YES, HE DIED ON THE (B)(6). WAS AN AUTOPSY DONE? IF YES, WHAT WAS THE CAUSE OF DEATH IN THE REPORT? NO AUTOPSY. IF NO AUTOPSY WAS DONE, WHAT WAS THE CAUSE OF DEATH AS ATTRIBUTED BY THE HOSPITAL/SURGEON?. WITH THE APPROVAL OF THE FAMILY, CARE WAS STOPPED, PATIENT DIED WHEN RESPIRATION STOPPED. IN ADDITION, I SPOKE WITH (B)(6), WHO ALSO MET WITH THE SURGEON. THE MESSAGE TO BOTH THE REP AND THE RSM IS THAT THE SURGEON DOES NOT WANT TO MEET WITH EES PERSONNEL. THE SURGEON IS QUESTIONING IF THE RELOAD WAS PROPERLY INSERTED INTO THE DEVICE, HOWEVER, NO WAY TO CONFIRM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SUPERIOR LOBECTOMY PROCEDURE, ON THE FIRST FIRING OF THE DEVICE, IT WAS PLACED AROUND THE PULMONARY ARTERY. WHEN IT WAS FIRED, THE SURGEON FELT SOMETHING DIFFERENT, IT WAS FOUND THAT THE DEVICE HAD ONLY CUT, IT DID NOT STAPLE. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE (IN EMERGENCY) TO REPAIR THE PULMONARY ARTERY. WHEN THIS WAS DONE, IT WAS NOTED THAT THE RELOAD WAS LYING IN THE PATIENT. PROCEDURE COMPLETED WITH SAME/LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4A235

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death