BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 1080010 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00538
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 25, 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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/17/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, UPON INSERTION OF THE DEVICE, THE RED SAFETY BUTTON IN DOWN POSITION (SAFETY OFF) FAILED TO RETURN TO THE UP POSITION (SAFETY ON). THIS OCCURRED ON TWO OF THE THREE INSERTIONS. THE CASE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1