BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1218603 · Received November 3, 2008

    Report

    Report Number
    3005075853-2008-02756
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/03/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OBTURATOR IS TOO BIG FOR THE TROCAR. IT'S A 12 OBTURATOR LABELED AS AN 11. PREOPERATIVE, NO PATIENT INVOLVEMENT.

    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 E4LX7E

    Patients

    Seq Age Sex Outcome Treatment
    1