BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH* XCEL TROCAR

    MDR report key: 1961753 · Received January 14, 2011

    Report

    Report Number
    1527736-2011-00018
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE FOLLOWING QUESTIONS WERE ASKED: 'PLEASE CONFIRM THE TROCAR PRODUCT CODE. WHAT WAS THE PATIENT'S POSITION UPON ENTRY? WHAT WAS THE ENTRANCE POINT OF THE TROCAR? WAS THIS THE PRIMARY PORT? WHAT SIZE SCOPE WAS BEING USED? DID THE SURGEON INSUFFLATE PRIOR TO INSERTION? PLEASE DESCRIBE THE CHAIN OF EVENTS AFTER THE AORTA WAS PUNCTURED. WAS THE PATIENT'S ANATOMY NORMAL? HOW FAMILIAR IS THE SURGEON WITH THE OPTICAL ENTRY TECHNIQUE? WHAT WERE THE PATIENT'S SEX, AGE, AND WEIGHT? PATIENT'S PRE-EXISTING CONDITIONS? WILL AN AUTOPSY BE PERFORMED? IF SO, IS IT POSSIBLE FOR THE COMPANY TO RECEIVE A COPY? WILL THE DOCTOR BE WILLING TO HAVE A CLINICAL CONVERSATION WITH A COMPANY SURGEON?' THE FOLLOWING COMMUNICATION WAS RECEIVED FROM THE REP DURING A VISIT TO THE HOSPITAL AND THE DOCTOR. HE WAS TOLD AT THIS TIME, ALL MATTERS REGARDING THE INCIDENT ARE BEING HELD PRIVATE BY THE HOSPITAL. IN THE FUTURE, IF THERE IS A TIME THEIR HOSPITAL TEAM AGREES TO ANSWER THE BELOW QUESTIONS, THEY WILL CONTACT US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE INJURED THE ABDOMINAL AORTA AND THE PATIENT DIED. IT IS UNKNOWN WHICH DEVICE WAS INVOLVED. NO OTHER DETAILS OF THE EVENT ARE PRESENTLY KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death