BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 1831700 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07698
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 24, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE INNER SEAL ASSEMBLY AND DUCKBILL DEFORMED AS THE OBTURATOR WAS RETURNED INSERTED THROUGH THE SLEEVE. THE SEAL SET CAUSED BY STERILIZATION WITH THE OBTURATOR INSERTED THROUGH THE SEAL GENERALLY INCREASES THE LEAK RATE. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE THE TROCAR WAS LEAKING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLUNT TIP TROCAR GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JA6K

    Patients

    Seq Age Sex Outcome Treatment
    1