BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55MM NTLC SELECTABLE RELOAD

    MDR report key: 2082097 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01864
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 15, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: PER RISK MANAGEMENT, THEY HAD USED THEIR LAST STAPLER IN THIS CASE AND DISCARDED IT AFTER THE CASE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: THE COLOSTOMY WAS TEMPORARY. INTER-OPERATIVELY THE SURGEON NOTED THE STAPLE LINE TO BE GOOD AND HEMOSTATIC. A BLUE FIRING WAS USED ON THE PATIENT. THE SURGEON TYPICALLY USES BLUE BUT UNDERSTANDS THAT THICKER TISSUE MAY REQUIRE A GREEN SETTING. THE TISSUE IN THIS CASE WAS NOT NOTED TO BE THICK. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: PATIENT IS FINE WITH A TEMPORARY ILEOSTOMY. THE SURGEON USED A BLUE FIRING FOR THE SIDE TO SIDE ANASTOMOSIS. EVERYTHING LOOKED FINE DURING THE CASE. PATIENT RETURNED WITH AN ABSCESS. DURING THE RE-OPERATION, THE SURGEON NOTICED THAT STAPLES IN THE MIDDLE OF THE LINE WERE MISSING. THE REP REVIEWED A PHOTO FROM THE SURGERY AND ESTIMATED A 15MM TO 20MM HOLE IN THE MIDDLE OF THE LINE IN THE SIDE TO SIDE ANASTOMOSIS. PATIENT WAS NOTED TO BE ANEMIC AT THE TIME OF SURGERY/RE-OPERATION. THE PATIENT CAME BACK TO HOSPITAL NINE DAYS POST OP DUE TO PAIN. THAT IS WHEN THE SURGEON PERFORMED THE RE-OPERATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON 8/15/2011: ADDITIONAL INFORMATION RECEIVED ON 09/01/2011 FROM EES CONSULTANT SURGEON: I HAVE HAD A CHANCE TO REVIEW SIX DIGITAL IMAGES OF THE SPECIMEN REMOVED IN REGARDS TO THIS EVENT (ATTACHED). IT CLEARLY DEMONSTRATES A SMALL APPROXIMATELY 1 ½ CM ENTEROTOMY IN THE AREA OF THE PREVIOUSLY STAPLED ANASTOMOSIS. UNFORTUNATELY, IT IS IMPOSSIBLE IN THESE IMAGES TO DETERMINE WHICH STAPLE LINE THIS REPRESENTS BUT MY CLINICAL OPINION IS THIS REPRESENTS THE 'TOPPING OFF' STAPLE LINE. IN THE IMAGES, IT IS OBVIOUS THAT THERE ARE WELL FORMED B TYPE STAPLES ON THE LEFT HAND SIDE AND FOR A DISTANCE OF THE ENTEROTOMY NO OBVIOUS STAPLES ON THE RIGHT SIDE. AT THE SUPERIOR ASPECT OF THE ENTEROTOMY, THERE DOES APPEAR TO BE A WELL FORMED STAPLE IN GOOD POSITION LIMITING FURTHER DISRUPTION. IT IS NOT CLEAR THE CAUSE OF THIS PARTICULAR ANASTOMOTIC BREAKDOWN. THE FACT THAT THERE ARE WELL FORMED STAPLES ON ONE SIDE OF THE ENTEROTOMY AND THE FACT THAT NEARLY TEN DAYS PROGRESSED BETWEEN INITIAL AND REOPERATIVE INTERVENTION WOULD LEAD ME TO BELIEVE THAT THE STAPLER FUNCTIONED APPROPRIATELY AND TISSUE FACTORS WERE MORE TO BLAME FOR THIS PARTICULAR EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 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 THE INITIAL EXPLORATORY LAPAROTOMY WITH BOWEL RESECTION PROCEDURE ON (B)(6) 2011 WENT WELL. ON (B)(6) 2011 THE PATIENT WAS READMITTED IN THE HOSPITAL. AN EXPLORATORY PROCEDURE WAS PERFORMED AND THERE WAS A LEAK IN THE ANASTOMOSIS. THE SURGEON PERFORMED A COLOSTOMY BUT IT IS UNKNOWN IF THE COLOSTOMY IS PERMANENT OR TEMPORARY. THE CASE WAS COMPETED WITH A GIA DEVICE. THE PATIENT IS STABLE AT THIS TIME.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55MM NTLC SELECTABLE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R