BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1910118 · Received February 5, 2008

    Report

    Report Number
    1527736-2008-00716
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 15, 2008
    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
    TX, 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 HAND ASSISTED HYSTERECTOMY, THE TROCAR LEAKING THROUGH THE SEALS. THEY COMPLETED THE CASE WITH THE DEVICE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG GCJ ETHICON ENDO-SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1