BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILS 25MM, CURVED

    MDR report key: 2962410 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00631
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 23, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. ADDITIONAL INFORMATION RECEIVED: ON WHAT TISSUE TYPE DID THE PROBLEM OCCUR? OESOPHAGO-JEJUNAL ANASTOMOSIS. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? GASTRIC CANCER. HAS THE PATIENT UNDERGONE ANY RADIATION OR CHEMO THERAPY? CHEMO ONLY. WERE THERE ANY COMORBIDITY CONCERNS (DIABETES, CROHNS, AUTO-IMMUNE DISORDERS, COAGULATION ISSUES, ETC.)? NO. IS A PATHOLOGY SPECIMEN AVAILABLE? YES, BUT WILL NOT BE RETURNED. ARE THERE ANY X-RAYS AND/OR PICTURE AVAILABLE FOR ANALYSIS? YES, CT YES BUT WILL NOT BE RETURNED. IS IT POSSIBLE TO HAVE A PEER TO PEER DISCUSSION WITH THE SURGERY? NO - WE HAVE DISCUSSED IT INTERNALLY AT THE UPPER GI M&M MEETING. AT WHAT TIME AFTER THE PROCEDURE WAS THE LEAK DETECTED? DAY 3. WHAT WAS THE QUALITY OF THE TISSUE? GOOD AND NORMAL. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? HAND TIED PURSE STRING. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? NAD. WAS THE ANVIL PUT ON THE TROCAR EXACTLY HORIZONTALLY? YES. PUTTING THE ANVIL ON THE TROCAR WERE ANY GRASPERS USED? YES. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED TO THE TROCAR OF THE DEVICE? VISUALLY, AND ORANGE COLOR MET THE ANVIL, AND CLUNK FELT. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? THIN AT 1.5MM. HOW THICK WAS THE TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? 1.5 MM , YES. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS BUTTRESSING MATERIAL UTILIZED? YES, 3/0 PDS. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WAS THE DEVICE COMPLETELY FIRED PLASTIC TO PLASTIC? YES. HOW WAS IT CONFIRMED THAT THE DEVICE WAS FULLY FIRED (CRUNCH, LEVER COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH, LEVER COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES, ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? 3/4 OF A TURN. WERE ANY ADDITIONAL STEPS TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS DURING INITIAL PROCEDURE (LEAK TEST, DONUT CONFIRMATION, ETC.)? YES, LEAK TEST, DONUT CONFIRMATION, OGD. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSES? CANCER, HEART DISEASE, DVT, PE, OBESE , HYPERTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A MINIMALLY INVASIVE ESOPHAGECTOMY PROCEDURE THERE WAS A LEAK FROM THE STAPLE LINE THAT THE STAPLER WAS USED TO FORM ON THE CONDUIT, ATTACHING THE ESOPHAGUS TO THE STOMACH POUCH. THE SURGEON DID NOT NOTICE ANY ISSUES DURING THE PROCEDURE BUT THE PATIENT DIED FOLLOWING THE OPERATION DUE TO A LEAK WHICH HE LOCATED AS A HOLE AT THE STAPLE LINE CREATED FROM THE DEVICE. THE PATIENT WAS IN INTENSIVE CARE AFTER A MAJOR OPERATION. THE PATIENT'S CONDITION WAS CRITICAL AFTER THE EVENT. THE PATIENT EXPIRED A WEEK AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64677 ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death