BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 11 MM DIAMETER - 100 MM LE

    MDR report key: 1250815 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03381
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 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

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE OBTURATOR AND CANNULA COULD NOT BE MATCHED. THE OBTURATOR COULD NOT PASS THROUGH THE CANNULA'S SEAL. THE OUTER SLEEVE WAS LABELED 11 MM. 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, 11 MM DIAMETER - 100 MM LE GCJ ETHICON ENDO-SURGERY, LLC NA E4LF4K

    Patients

    Seq Age Sex Outcome Treatment
    1