BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100MM SLEE

    MDR report key: 1003623 · Received February 15, 2008

    Report

    Report Number
    1527736-2008-00931
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP BOWEL PROCEDURE THAT THE TROCAR WAS LEAKING GAS FROM THE SEAL, LOSING PNEUMO IN THE ABDOMEN. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100MM SLEE GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JU4X

    Patients

    Seq Age Sex Outcome Treatment
    1