BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILS CIRCULAR STAPLER

    MDR report key: 3808621 · Received May 13, 2014

    Report

    Report Number
    3005075853-2014-03233
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS ANYTHING UNUSUAL NOTICED DURING THE FIRST SURGERY? NO. DID THE SURGEON OR ANYONE ELSE MENTIONED DIFFICULTIES WITH THE DEVICE DURING THAT SURGERY? NO. ON WHAT TISSUE TYPE WAS THE DEVICE USED? WHAT WAS THE QUALITY OF THE TISSUE? INTESTINE- NORMAL QUALITY. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED TO THE TROCAR OF THE DEVICE? EVERYTHING WAS NORMAL. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO, BUTTRESSING MATERIAL WAS USED. AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? YES, NO ANOMALY. WERE ANY ADDITIONAL STEPS TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS (LEAK TEST, DONUT CONFIRMATION, ETC.)? YES, PNEUMATIC TRIAL AND HISTOLOGICAL EXAM OF PERIANASTOMOTIC RINGS WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE) HAND TIED RAKE TECHNIQUE. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? IT WAS ANASTOMOSIS END TO END. THE RECTUM WAS SECTIONED WITH ENDO; THE INSERTION WAS TAKEN MARGINALLY TO THE SUTURE LINE AND NOT OVERLAPPED. HOW THICK WAS THE TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? THE INDICATOR WAS IN THE RANGE. NO ISSUE WITH TENSION WAS THE ANVIL PUT ON THE TROCAR EXACTLY HORIZONTALLY? YES. PUTTING THE ANVIL ON THE TROCAR WERE ANY GRASPERS USED? YES. WAS THE DEVICE COMPLETELY FIRED PLASTIC TO PLASTIC? YES. WAS THE TARGET TISSUE FULLY CUT CIRCUMFERENTIALLY? DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT¿S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? NO. HOW MUCH BLOOD DID THE PATIENT LOST? WAS A TRANSFUSION REQUIRED?3.5 GR OF HEMOGLOBIN. 4 TRANSFUSION. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. YES, CALCIUM HEPARIN DOES PATIENT HAVE A KNOWN COAGULATION DISORDER? NO. HAS THE PATIENT TAKEN ANY STEROIDS? NO. WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? NORMAL. WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? HE LOST 3.5 G OF HEMOGLOBIN. WHAT WERE THE PATIENT¿S PRE-OP DIAGNOSIS, DID HE/SHE SUFFERS FROM CANCER, MORBUS CROHN OR COLITIS ULCEROSA? CANCER OF SIGMA. IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NO. WAS THE SECOND PROCEDURE ONLY CAUSED BY THE DIFFICULTIES WITH THE DEVICE? OR WERE THERE OTHER CIRCUMSTANCES, PATIENT CONDITIONS OR SURGEON¿S PREFERENCES THAT MAY HAVE CAUSE THE ADDITIONAL PROCEDURE? WERE THERE OTHER CIRCUMSTANCES, PATIENT CONDITIONS OR SURGEON¿S PREFERENCES THAT MAY HAVE CAUSE THIS? AFTER 48 HOURS OCCURRED THE FISTULISATION OF THE ANASTOMOSIS. THE PATIENT STOPPED TO BLEED 12-18 HOURS AFTER THE INTERVENTION, BUT SUBSEQUENTLY HAPPENED A FISTULISATION WITH FATAL SEPTIC SHOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC SIGMA RESECTION PROCEDURE, IN THE NIGHT AFTER THE PROCEDURE A BLEEDING OF THE ANASTOMOTIC LINE OF THE PATIENT HAPPENED. THE SURGEON REFERRED THAT HE PERFORMED THE PNEUMATIC TEST WITH GOOD OUTCOME AND THE TISSUE TEST REVEALED INTACT PERI ANASTOMOTIC RINGS. AFTER SECOND PROCEDURE, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286908 ILS CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death