BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 1891687 · Received November 5, 2010

    Report

    Report Number
    3005075853-2010-06316
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 18, 2010
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 21 OCT 2010: WAS THE INSUFFICIENCY OF THE ANASTOMOSIS DETECTED FIVE DAYS AFTER SURGERY, OR EARLIER AND ONLY THE REOPERATION TOOK PLACE FIVE DAYS AFTER SURGERY? IT WAS DETECTED AFTER 5 DAYS AND WAS OPERATED ON THE SAME DAY. WERE INTRAOPERATIVE TESTING'S OK? YES. IS IT POSSIBLE THAT THE ANASTOMOSIS WAS MADE UNDER TENSION? UNK. WHAT WERE THE PATIENTS PREEXISTING CONDITIONS, ESPECIALLY TISSUE CONDITIONS? UNK. ADDITIONAL INFORMATION RECEIVED ON 2 NOV 2010: DOCTOR CONFIRMED THAT AN OPEN ANASTOMOSIS (5 TH DAY POST-OPERATIVELY) CANNOT BE IN CONNECTION WITH OUR INSTRUMENT. THE ROOT CAUSE NEEDS TO BE SOMETHING DIFFERENT. PLEASE REFER TO THE DOCTOR'S WORDING BELOW, WHERE IT IS STATED THAT THERE IS QUANTITY OF OPEN ANASTOMOSIS WHERE THE REASON IS UNKNOWN. "DEAR COLLEAGUES, REGULARLY, WE ARE ALL SHOCKED BY THE NEWS OF ANASTOMOTIC LEAKAGE OCCURRED IN THE LOWER GASTROINTESTINAL TRACT ASSOCIATED WITH ONE OF OUR STAPLERS, WITH GOOD REASON, BECAUSE AI'S ARE AMONG THE MOST COMMON (2 TO 15.9%) AND MOST FEARED COMPLICATIONS AFTER BOWEL RESECTION. TWO RECENT SURVEYS (2004, IN THE (B)(6) AND 2006 IN A PHD THESIS FROM (B)(6) CONCERNING RISK FACTORS FOR AI) COME TO THE CLEAR CONCLUSION THAT THE OCCURRENCE OF AN ANASTOMOTIC LEAK IS OF MULTIFACTORIAL ORIGIN. THE FIRST MAJOR CATEGORY IS THE SURGICAL-TECHNICAL SIDE, OUR INSTRUMENTS ARE INVOLVED. HERE IS THE MOST IMPORTANT PREREQUISITE FOR A FUNCTIONING ANASTOMOSIS A NONTRAUMATIC SURGICAL TECHNIQUE TO AVOID STRESS AND DISTURBED BLOOD FLOW. THE SECOND CATEGORY RELATES TO THE RISK FACTORS OF THE PATIENT, SIGNIFICANT PREVIOUS ALCOHOL CONSUMPTION, RADIATION, AND CORTISONE THERAPY AND THE ADMINISTRATION OF ERYTHROCYTE CONCENTRATES DURING SURGERY. THE LOCATION OF THE ANASTOMOSIS, SMOKING AND TAKING OTHER MEDICAMENTS PLAY IN SOME BUT NOT ALL STUDIES, AN IMPORTANT ROLE. (B)(6), MD, PROJECT MANAGER (B)(6)." ADDITIONAL INFORMATION RECEIVED ON 5 NOV 2010: AS THE ANASTOMOSIS WAS FINE FOR 5 DAYS WE DO NOT CONSIDER THAT THIS COMPLAINT IS CONNECTED TO THE INSTRUMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. 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 AFTER A RIGHT HEMICOLECTOMY PROCEDURE, ANASTOMOSIS WAS INSUFFICIENT AT FIVE DAYS POST-OPERATIVE; REOPERATION; SUTURED BY HAND. NO FURTHER INFORMATION IS AVAILABLE. THE CUSTOMER DISPOSED OF THE DEVICE AND THE RELOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TT9A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R RELOAD SR75, LOT#- G4TT0A