BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2963055 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00632
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ONE PIECE SLED REP PROVIDED THE FOLLOWING: A MALE PATIENT HAD A SLEEVE GASTRECTOMY ON THURSDAY ((B)(6)). DURING THE INITIAL PROCEDURE, ON THE SECOND FIRING, USING THE BLACK LOAD, THE DEVICE FIRED ONLY A SMALL PORTION AND A LOUD CRUNCHING SOUND WAS HEARD. IT WAS DESCRIBED TO THE SALES REPRESENTATIVE AS "PLASTIC BREAKING." THE FIRING WAS COMPLETED. WHEN THE SURGEON OPENED THE DEVICE, THE OUTER TWO ROWS OF STAPLES WERE UNFORMED ON THE PATIENTS SLEEVE SIDE. A PIECE OF PLASTIC WENT INTO THE PATIENT'S BODY CAVITY. THE PIECE OF PLASTIC WAS RETRIEVED. THE CASE WAS COMPLETED WITH THE SAME DEVICE WITH GREEN RELOADS. PATIENT WAS RELEASED AND READMITTED TO THE HOSPITAL OVER THE WEEKEND. AFTER 3 DAYS THE PATIENT EXPIRED. THE SURGEON WAS NOT NOTIFIED THAT THE PATIENT HAD RETURNED TO THE HOSPITAL BECAUSE THE HOSPITAL BELIEVED IT TO BE UNRELATED TO THE PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. THE DEVICE USED WITH THE BLACK CARTRIDGE WAS DISCARDED BUT THE CARTRIDGE WILL BE RETURNED FOR ANALYSIS. ON (B)(6) 2013 ETHICON CROSS FUNCTIONAL TEAM SPOKE WITH THE SURGEON. THE SURGEON WAS PERFORMING A SLEEVE GASTRECTOMY ON A (B)(6) MALE WITH A BMI OF 43. THE SURGEON REPORTED THAT HE TYPICALLY USES BUTTRESS ON ALL STOMACH FIRINGS IN THE GASTRECTOMY. DURING THE SECOND FIRING (STRAIGHT UP TOWARD THE DIAPHRAGM) WITH A BLACK CARTRIDGE THE DEVICE WAS CLAMPED DOWN AND COMPRESSION WAS ESTABLISHED. THE FIRING STROKE WAS STARTED FOR APPROXIMATELY 1CM TO ALLOW FOR COMPRESSION, THE DEVICE WAS THEN FIRED FOR AN ADDITIONAL 1-1.5CM. THEN AGAIN FOR A 3RD TIME AND THE "HANDLE PRODUCED A CLICK AND THE MOTOR SOUNDED BAD." ON THE SLEEVE SIDE 2 ROWS CLOSET TO BLADE THERE WAS NO STAPLE FORM BUT THE STAPLES WERE IN THE TISSUE. ALL OF THE UNFORMED STAPLES WERE THEN REMOVED AND A NEW STAPLER WAS USED WITH A GREEN CARTRIDGE. SINCE BUTTRESS WAS ALREADY PRESENT, NO ADDITIONAL BUTTRESS WAS USED WITH THE GREEN. THE SURGEON ADDED THAT "THE BLADE SEEMS TO BE GETTING PUSHED OVER AND CATCHING ON THE SIDE OF THE CARTRIDGE." THE SURGEON ALSO REPORTED THAT HE IS CAREFUL TO ENSURE THE "BLADE IS RIGHT IN THE MIDDLE OF THE LAST FIRING." TWO DAYS POST OPERATIVELY THE PATIENT RETURNED TO THE HOSPITAL AFTER "GOING DOWN" IN FRONT OF HIS PARTNER. ACCORDING TO THE SURGEON IT SOUNDED AS IF IT WAS CARDIAC RELATED; BUT NO AUTOPSY WAS PERFORMED. THE PATIENT WAS BACK IN THE HOSPITAL FOR 3 DAYS BEFORE HE EXPIRED. UPON THE PATIENT'S RETURN TO THE HOSPITAL THE PATIENT DID NOT EXHIBIT SIGNS OF TACHYCARDIA, NO FEVER OR INCREASE IN THE HEMOGLOBIN. NOTHING WAS SEEN ON THE ABDOMINAL CT SCAN. PULMONARY EMBOLISM WAS RULED OUT AND AN ECHOCARDIOGRAM REVEALED ABOUT 10% EJECTION FRACTION. PATIENT HAD STENTS PLACED 3 YEARS PRIOR. THE SURGEON HAD WORKED WITH CARDIOLOGY TO DEVELOP A PLAN FOR THE PATIENT PRIOR TO THE SLEEVE PROCEDURE. PLAVIX WAS DISCONTINUED 7 DAYS BEFORE THE PROCEDURE AND PLANNED TO RESUME 7 DAYS POST OP; HOWEVER, PATIENT WAS ON LOVENOX THE ENTIRE TIME. PER, ETHICON MEDICAL DIRECTOR, BASED ON THE CONVERSATION WITH THE SURGEON, "IT IS MY STRONG MEDICAL OPINION THAT THIS PATIENT DIED OF A CARDIAC EVENT, SECONDARY TO THE SURGICAL REQUIREMENT TO STOP ANTI-PLATELET THERAPY IN THE FACE OF SEVERE CARDIOVASCULAR DISEASE; NOT AS A RESULT OF A STAPLE MISFIRING THAT WAS RECOGNIZED AND CONTROLLED A THE TIME OF THE INITIAL SURGERY." THE INDICATORS OBSERVED IN PHOTOGRAPH, CONFIRMS THE PRODUCT INQUIRY'S DESCRIPTION OF THE COMPLICATION EXPERIENCED DURING THE PROCEDURE. HOWEVER BASED ON WHAT COULD BE OBSERVED IN ONE PHOTOGRAPH, SHOWING ONLY A PARTIAL STAPLE CARTRIDGE. IT CANNOT WITH ANY CONFIDENCE BE DETERMINED WHAT MAY HAVE CAUSED THE CARTRIDGE DAMAGE. SINCE THE DEVICE AND STAPLE CARTRIDGE ARE BEING RETURNED PHYSICALLY ANALYZING THE STAPLE CARTRIDGE FROM VARIOUS ANGLES AND VIEWS MAY RESULT IN A MORE CONCLUSIVE FINDING. THE ANALYSIS FOUND THAT ONE ECR60T CARTRIDGE WAS RECEIVED FOR ANALYSIS. UPON EVALUATION THE CARTRIDGE BODY, THE ONE PIECE SLED, AND SEVERAL DRIVERS WERE FOUND DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTICE, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, ON THE SECOND FIRING, USING THE BLACK LOAD, THE DEVICE FIRED ONLY A SMALL PORTION AND A LOUD CRUNCHING SOUND WAS HEARD. IT WAS DESCRIBED TO THE SALES REPRESENTATIVE AS "PLASTIC BREAKING." THE FIRING WAS COMPLETED. WHEN THE SURGEON OPENED THE DEVICE, THE OUTER TWO ROWS OF STAPLES WERE UNFORMED ON THE PATIENTS SLEEVE SIDE. A PIECE OF PLASTIC WENT INTO THE PATIENT'S BODY CAVITY. THE PIECE OF PLASTIC WAS RETRIEVED. THE SURGEON USED THE SAME GUN WITH A GREEN RELOAD TO FIX THE DEFECT. THE CASE WAS COMPLETED USING ALL GREEN RELOADS. SEAM GUARD BUTTRESSING MATERIAL WAS USED ON ALL FIRINGS. THE DEVICE WAS NOT FIRED ACROSS AN EXISTING STAPLE LINE OR CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69068 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ECR60T LOT#: UNKNOWN