BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1003653 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00877
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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 THE SEAL WAS LEAKING DURING THE CASE. THEY TRIED USING A ANOTHER DEVICE AND IT ALSO LEAKED, SO THEY COVER THE TOP OF THE DEVICE AND DEALT WITH THE ISSUE AND COMPLETED THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICES ARE AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM GCJ ETHICON ENDO-SURGERY, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1