BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 1121264 · Received August 18, 2008

    Report

    Report Number
    3005075853-2008-01254
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 4, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, DURING INSERTION OF A SECOND PORT, THE TROCAR REMAINED LOADED AFTER PENETRATING THE ABDOMINAL WALL. MEANING THE SAFETY MECHANISM DID NOT BOUNCE BACK AFTER PENETRATION. THE INSERTION WAS UNDER VISION. ACCORDING TO THE SURGEON, THE ABDOMINAL WALL WAS NORMAL. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR 11MM GCJ ETHICON ENDO-SURGERY, LLC NA E4LA4G

    Patients

    Seq Age Sex Outcome Treatment
    1