BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1924646 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07079
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT ONLY THE UNIVERSAL SEAL ASSEMBLY WAS RECEIVED FOR ANALYSIS. NO FUNCTIONAL TESTING COULD BE PERFORMED. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC PROCEDURE, THE DEVICE SEAL WAS LEAKING AND THERE WAS LOSS OF PNEUMO. NO ADDITIONAL INFORMATION IS AVAILABLE ABOUT THIS EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4U57R

    Patients

    Seq Age Sex Outcome Treatment
    1