BEUDAMED
    FDA Adverse Event Death Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2213059 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03332
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: WAS THE SURGEON AND O.R. STAFF THOROUGHLY IN-SERVICED ON THE STEPS OF USE PRIOR TO THE USE OF THE NTLC? YES. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? FIRST TIME USER WAS THE SALES REP PRESENT DURING THE SURGEON'S FIRST FEW CASES TO INSURE THE INSTRUMENT WAS USED IN ACCORDANCE WITH THE IFU? YES. WAS THE REP PRESENT FOR THIS CASE? YES. WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? BLUE. DID THE SURGEON WAIT 15 SECONDS AFTER CLAMPING AND PRIOR TO FIRING FOR OPTIMAL COMPRESSION? FIRST FIRING, YES. SECOND FIRING, STARTED TO FIRE WITHOUT THE PAUSE, BUT PAUSED JUST AFTER INITIALIZING THE FIRING SEQUENCE. AFTER THE PAUSE HE COMPLETED THE FIRING. THIRD FIRING, YES. DID ANYONE MOVE THE FIRING KNOB TO THE LEFT OR RIGHT AFTER LOADING THE DEVICE BUT BEFORE FIRING? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. DID THE STAPLE LINE APPEAR TO BE INTACT DURING THE OPERATION? YES. WAS ANOTHER STAPLING DEVICE INVOLVED? (I.E., CDH, TL, TX, ETC.) NO. WHAT IS THE CURRENT STATUS OF THE PATIENT? DECEASED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WHAT AREA OF THE STAPLE LINE DID THE TISSUE BECOME NECROTIC? INITIAL TRANSECTION OF SMALL BOWEL. WHAT WERE THE QUALITY AND/OR THICKNESS OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? (FRIABLE, THIN, REGULAR, THICK, ETC.)? REGULAR, GOOD BLOOD SUPPLY WAS THERE AN INSPECTION OF THE STAPLE LINE ON BOTH SIDES OF THE TISSUE (I.E., ANTERIOR / POSTERIOR)? IF YES, WHAT DID IT SHOW? YES, EVERYTHING WAS INTACT. WAS A LEAK TEST COMPLETED? NO. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT'S HEALTH/SURGICAL OUTCOME? CANCEROUS COLON. HOW MANY DAYS POST OP WAS THE PATIENT RETURNED TO SURGERY? 4 DAYS. ON WHAT DATE WAS THE PATIENT RETURNED TO SURGERY? (B)(6) 2011. ON WHAT DATE DID THE PATIENT EXPIRE? (B)(6) 2011. WHAT WAS THE PATIENT'S CAUSE OF DEATH? SEPTICEMIA. WAS AN AUTOPSY COMPLETED? NO. WHAT WAS THE AGE AND SEX OF THE PATIENT? MALE, (B)(6). IS A PATHOLOGY SPECIMEN AVAILABLE? UNCERTAIN. ARE ANY PICTURES OR IS A DVD OF THE CASE AVAILABLE? NO. WOULD THE SURGEON BE WILLING TO SPEAK TO AN EES MD REGARDING THE EVENT? NOT AT THIS STAGE BUT HE WILL APPRECIATE OUR FEEDBACK THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE SURGEON USED THE DEVICE FOR RESECTION AND ANASTOMOSIS OF BOWEL. INITIAL PROCEDURE WENT WELL. HOWEVER, AFTER A FEW DAYS, SOME TISSUE ALONG ONE OF THE STAPLE LINES BECAME NECROTIC. THE PATIENT HAD TO BE TAKEN INTO SURGERY TO RECTIFY THE SITUATION. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O| R CARTRIDGE