BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG

    MDR report key: 1210270 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02479
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 26, 2008
    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

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONLY A SEAL OF THE INSTRUMENT WAS RETURNED FOR ANALYSIS. IT WAS LEAK TESTED WITH A TEST SLEEVE AND FAILED. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE LEAK ISSUE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. WE DID NOT RECEIVE A VALID BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAR PROCEDURE, THERE WAS AN ABDOMINAL AIR LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER, 100MM LENG GCJ ETHICON ENDO-SURGERY, LLC NA E4LE2X

    Patients

    Seq Age Sex Outcome Treatment
    1