BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM L

    MDR report key: 1629787 · Received March 8, 2010

    Report

    Report Number
    3005075853-2010-01092
    Event Type
    Death
    Date Received
    March 8, 2010
    Date of Event
    December 1, 2009
    Report Date
    February 10, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. THIS EVENT OCCURRED BEFORE CHRISTMAS BUT HAS ONLY BEEN REPORTED NOW. THE CLINICAL LEAD AT (B) (6) INFORMED REP THAT ONE OF HIS COLLEAGUES HAD AN INCIDENT INVOLVING AN XCEL BLADELESS TROCAR USED UNDER OPTICAL ENTRY. DURING ENTRY, A LARGE BLOOD VESSEL WAS DAMAGED AND APPARENTLY THIS LED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN CASE, THE TROCAR WAS BEING USED UNDER OPTICAL ENTRY. DURING ENTRY, A LARGE BLOOD VESSEL WAS DAMAGED AND APPARENTLY THIS LED TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED AT THIS TIME. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM L GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death