BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1931208 · Received December 17, 2010

    Report

    Report Number
    3005075853-2010-07230
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE DUCKBILL PARTIALLY DETACHED FROM THE SLEEVE; HOWEVER, NO DAMAGE WAS NOTED ON THE DUCKBILL. A POSSIBLE CAUSED OF THE EVENT REPORTED IS WHEN THE DUCKBILL GOT PARTIALLY DETACHED FROM THE SLEEVE IT SEEMS LIKE THE DUCKBILL WAS TORN. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE SEAL ISSUES. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SEAL TORE ON DEVICE WHILE REMOVING A RAY-TEC SPONGE. NO PIECE OF DEVICE FELL INTO THE PATIENT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1