BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1871407 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05891
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HERNIA PROCEDURE, THE DEVICE WAS LEAKING FROM THE VALVES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1