BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 1112796 · Received August 12, 2008

    Report

    Report Number
    3005075853-2008-01125
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    February 16, 2008
    Report Date
    July 28, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESET BUTTON. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE D11LT INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS FUNCTIONALLY EVALUATED, AND THE RESET BUTTON AND BULLET FAILED TO RETURN TO THE ORIGINAL POSITION UPON CUTTING, AND ADVANCING THROUGH THE SKIN TEST MEDIA; THUS LEAVING THE BLADE EXPOSED UPON ADVANCEMENT. THE FAILURE WAS NOTED DURING THREE NON-CONSECUTIVE TEST SEQUENCES. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 A CHOLECYSTECTOMY PROCEDURE, THE DEVICE COULD NOT HOLD THE BLADE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR 11MM GCJ ETHICON ENDO-SURGERY, LLC NA D4JH3T

    Patients

    Seq Age Sex Outcome Treatment
    1