BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2003914 · Received March 1, 2011

    Report

    Report Number
    3005075853-2011-00783
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE (A) FOUND THAT THE DEVICE WAS RECEIVED WITH THE DUCKBILL OUT OF POSITION AND DAMAGED. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED SEAL ISSUES. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS OF THE DEVICE (B) FOUND THAT IT WAS RECEIVED WITH THE DUCKBILL PARTIALLY DETACHED FROM THE SLEEVE CAUSING THE DUCKBILL TO REMAIN OPEN AT THE SLIT; THIS CONDITION LEAD TO THE REPORTED LEAKING ISSUES. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE SEAL ISSUES. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. DEVICE B ADDITIONAL INFORMATION: BATCH # G9KP1E, EXPIRATION DATE: 06/2015, MANUFACTURING DATE: 07/2010. (B)(4): DUCKBILL. THE ANALYSIS RESULTS OF THE DEVICE (C) FOUND THAT IT WAS RECEIVED INSIDE ITS ORIGINAL PACKAGE. FURTHER EVALUATION FOUND THAT THE SEAL MECHANISM WAS IN GOOD CONDITION; NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. DEVICE C ADDITIONAL INFORMATION: BATCH # G9KP1E, D4: EXPIRATION DATE: 06/2015, H2: MANUFACTURING DATE: 07/2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BANDING PROCEDURE, THE SAGB WAS PASSED THROUGH THE TROCAR AND THE SEAL FELL OUT OF THE TROCAR INTO THE PATIENT. THE SEAL WAS WRAPPED AROUND THE BAND AND THE SURGEON HAD TO CUT THE SEAL OFF THE BAND. THE PROCEDURE HAD TO BE CONVERTED TO OPEN. A SECOND TROCAR WILL ALSO BE RETURNED AS THIS WAS FOUND TO BE EXCESSIVELY LEAKING WHEN THIS WAS REPLACED DURING THE PROCEDURE.

    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 G4TL5K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GASTRIC IMPLANT