BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 1973929 · Received January 31, 2011

    Report

    Report Number
    3005075853-2011-00347
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    July 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO LAPAROSCOPY PROCEDURE, IT WAS VERIFIED THAT THERE WAS A GAS LEAK CONSTANTLY, IN THE TROCAR, TO INTRODUCING ANY 5 MM FORCEPS. IT WAS NECESSARY TO USE A REPLACEMENT FOR ANOTHER 12 MM TROCAR. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RN11

    Patients

    Seq Age Sex Outcome Treatment
    1