BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 5MM DIAMTER, 150MM LENGTH

    MDR report key: 1830300 · Received January 2, 2008

    Report

    Report Number
    1527736-2008-00037
    Event Type
    Malfunction
    Date Received
    January 2, 2008
    Date of Event
    November 27, 2007
    Report Date
    December 19, 2007
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE PORT WAS LEAKING GAS. MANUALLY CLOSED THE VALVE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 5MM DIAMTER, 150MM LENGTH GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HX5J

    Patients

    Seq Age Sex Outcome Treatment
    1