BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR - 5 MM DIAMETER, 100 MM LENG

    MDR report key: 1820610 · Received September 13, 2007

    Report

    Report Number
    1527736-2007-06050
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    August 24, 2007
    Report Date
    August 31, 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
    UT, US
    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 THERE WAS AN ISSUE WITH THE INNER SEAL OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR - 5 MM DIAMETER, 100 MM LENG GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HA9W

    Patients

    Seq Age Sex Outcome Treatment
    1