BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR

    MDR report key: 1082932 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00702
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPY DIAGNOSTIC PROCEDURE, THE INSERTION TIP OF THE INSTRUMENT BROKE OFF. THE TIP WAS RETRIEVED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PATIENT IS DOING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR GCJ ETHICON ENDO-SURGERY, LLC. NA E4KP7F

    Patients

    Seq Age Sex Outcome Treatment
    1