BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 2070451 · Received April 27, 2011

    Report

    Report Number
    3005075853-2011-01741
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 7, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT THE SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WAS LEAKAGE FROM THE TROCAR. NO OTHER DETAILS OF THE EVENT WERE PROVIDED. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR 11MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK G4U081

    Patients

    Seq Age Sex Outcome Treatment
    1