BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR 11MM

    MDR report key: 1121924 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01174
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 30, 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

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, DURING INSERTION OF THE FIRST TROCAR AT THE UMBILICUS, THE TROCAR PENETRATED THE ABDOMINAL WALL BUT THE KNIFE REMAINED LOADED. ACCORDING TO THE SURGEON, THIS PATIENT HAD A 'WEAK" ABDOMINAL WALL, COMPRISED OF A LOT OF FAT AND A VERY THIN FASCIA. THE CASE WAS COMPLETED WITH ANOTHER DEVICE.

    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