BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 3994165 · Received August 8, 2014

    Report

    Report Number
    3005075853-2014-05562
    Event Type
    Death
    Date Received
    August 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MANY HOURS AFTER THE PROCEDURE DID THE HEMORRHAGE OCCUR? THE HEMORRHAGE OCCURRED FEW MINUTES FROM THE BEGINNING OF THE INTERVENTION. WHAT WAS THE ENTRANCE POINT OF THE TROCAR? THE TROCAR WAS POSITIONED IN SUPRA-UMBILICAL POSITION. WHAT WAS THE PATIENT¿S POSITION UPON ENTRY? SUPINE. WAS THIS THE PRIMARY PORT? WHAT SIZE SCOPE WAS BEING USED? 12 MM. WAS THE PATIENT¿S ANATOMY NORMAL? REGULAR. HOW FAMILIAR IS THE SURGEON WITH THE USE OF THE DILATED TROCAR? THE SURGEON IS EXPERT IN THE USE OF TROCAR WITH BLADE. DID THE SAFETY SYSTEM KNIFE WORK AS EXPECTED? YES. DID THE SURGEON INSUFFLATE PRIOR TO INSERTION? THE ABDOMEN WAS INSUFFLATED BEFORE INTRODUCING THE BLADE. WAS THE LESION OF THE AORTA IN THE REGION WHERE THE TROCAR WAS INSERTED? THE LESION WAS IN CORRESPONDENCE OF THE TROCAR. DID THE OPERATING SURGEON ATTEMPT TO REPAIR THE AORTA? THE SURGEON SUTURED MANUALLY THE AORTA (OPEN SURGERY). PLEASE EXPLAIN THE CHAIN OF EVENTS AFTER THE VESSEL WAS PUNCTURED? FOLLOWING THE LESION, A STRONG HEMORRHAGIC SHOCK OCCURRED AND ALL THE PRESSURE VALUES ALTERED. PATIENT¿S WEIGHT? PRE-EXISTING CONDITIONS? (B)(6). WAS AN AUTOPSY PERFORMED? IF SO, IS A COPY AVAILABLE FOR REVIEW? YES THE AUTOPSY HAS BEEN MADE; IT¿S NOT AVAILABLE AS A COPY. WAS THE DEVICE REPROCESSED? NO. IS THE SURGEON WILLING TO HAVE A PEER TO PEER CONVERSATION WITH ETHICON MEDICAL DIRECTOR? THE SURGEON IS NOT AVAILABLE TO HAVE A PEER TO PEER WITH JNJ PERSONNEL ALSO BECAUSE ACCORDING TO HIM THE DEVICE WAS WORKING PROPERLY. WAS THE AORTIC BLEEDING NOTICED DURING THE PRIMARY OPERATION? THE BLEEDING WAS IMMEDIATELY IDENTIFIED. IF SO, WHAT WAS INITIALLY DONE TO ADDRESS THE BLEEDING? IT WAS MADE A LAPAROTOMY TO STOP THE BLEEDING WHEN AND HOW WAS BLEEDING IDENTIFIED? THE BLEEDING WAS IDENTIFIED IMMEDIATELY DUE TO THE IMMEDIATE CHANGE OF PATIENT¿S HEALTH AND FOR THE HIGH BLEEDING. WHAT ATTEMPTS WERE MADE TO ADDRESS THE BLEEDING IF AN ADDITIONAL PROCEDURE WAS REQUIRED? THE BLEEDING WAS STOPPED BY MAKING A SUTURE OF THE DAMAGED AORTA. IS IT BEING IMPLIED THAT THE TROCAR HIT THE AORTA AND CAUSED THE INITIAL ISSUE RESULTING IN THE REPAIR OF THE AORTA? YES, IT HAS BEEN NOTICED THAT THE TROCAR SEVERED THE AORTA CAUSING BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SLEEVE GASTRECTOMY PROCEDURE, IN WHICH A TROCAR WAS USED, THE PATIENT DIED AFTER A SERIOUS HEMORRHAGIC SHOCK CAUSED BY AN AORTIC LESION. ACCORDING TO THE SURGEON, THE TROCAR WAS WORKING WELL. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472491 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death