BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP

    MDR report key: 1934605 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07304
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 6, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THEY ENCOUNTERED SIGNIFICANT GAS LEAKING FROM WHAT THEY IDENTIFIED AS COMING FROM THE TROCAR SEAL. THEY CONTINUED AND FINISHED THE CASE AS PLANNED. NEW TROCARS WERE USED TO COMPLETE THE PROCEDURE AS PLANNED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4U45H

    Patients

    Seq Age Sex Outcome Treatment
    1