BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP

    MDR report key: 1933930 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07302
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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 SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. 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 THE DEVICE WAS LEAKING PNEUMO. THE DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    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 G4U081

    Patients

    Seq Age Sex Outcome Treatment
    1