BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2100624 · Received May 24, 2011

    Report

    Report Number
    3005075853-2011-02099
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 10, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. A 5MM FORCEPS WAS USED WITH THE TROCAR. WHILE THE FORCEPS WAS BEING INSERTED, AIR DID NOT LEAK.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RECEIVED WITH THE CAP SEPARATED FROM THE SLEEVE; THE POSTS AND POCKETS WERE NOTED TO BE BROKEN AND CRACKED. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. 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 B ADDITIONAL INFORMATION: BATCH # H9051G; EXPIRATION DATE: 12/2015; MANUFACTURING DATE: 01/2011. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (C) WAS RECEIVED WITH THE CAP SLIGHTLY SEPARATED FROM THE SLEEVE; ONE POST AND POCKET WERE NOTED TO BE CRACKED. A POTENTIAL CAUSE OF THIS CONDITION IS THE REPEATED USE OF ETO AS A STERILIZATION AGENT. SINGLE-USE TROCARS ARE NOT TO BE REUSED, REPROCESSED OR RE-STERILIZED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. DEVICE C ADDITIONAL INFORMATION: BATCH # H9051G; EXPIRATION DATE: 12/2015; MANUFACTURING DATE: 01/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, AIR LEAKED WITH A BOO SOUND. THE EVENT OCCURRED AFTER A FORCEPS WAS REMOVED FROM THE DEVICE. THE EVENT OCCURRED IN EACH DEVICE. THE ABDOMINAL AIR PRESSURE WAS 10 MMHG/MIN AND HIGH FLOW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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 H4368T

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MM FORCEPS