BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 3941168 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05033
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE B12LT DEVICE WAS RETURNED IN GOOD CONDITION. THE DEVICE WAS VISUALLY INSPECTED AND NO MISSING PIECES WERE OBSERVED FROM THE SEALING COMPONENTS AND THE UNIVERSAL SEAL COULD BE ASSEMBLED AND DISASSEMBLED WITH NO ANOMALIES NOTED. THE INSTRUMENT WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE OUTER SEAL FELL OFF. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419707 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA L4E80K

    Patients

    Seq Age Sex Outcome Treatment
    1