BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5MM DIAMETER-75MM LENGTH

    MDR report key: 1211891 · Received October 23, 2008

    Report

    Report Number
    3005075853-2008-02534
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, AIR LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5MM DIAMETER-75MM LENGTH GCJ ETHICON ENDO-SURGERY, LLC. NA E4LE5X

    Patients

    Seq Age Sex Outcome Treatment
    1