BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM

    MDR report key: 1031258 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02289
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 25, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN TROCAR WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS. UNABLE TO DETERMINE AT THIS TIME IF IT IS A EES, REUSABLE OR COMPETITOR TROCAR. THE PATIENT SUFFERED A AORTIC INJURY. THE PATIENT HAS SOME SERIOUS COMPLICATIONS, BUT IT IS UNKNOWN AT THIS TIME WHAT THEY ARE. IT IS BELIEVED THAT THE PATIENT REQUIRED A AMPUTATION OF A LOWER EXTREMITY. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S