BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP TROCAR

    MDR report key: 1080403 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00388
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 19, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE RESECTION PROCEDURE, A LEAK OCCURRED THROUGH THE TROCAR BY USING/MOVING 5MM (REUSABLE), 10MM (DISPOSABLE) AND 12MM INSTRUMENTS (DISPOSABLE) INSTRUMENTS. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL DILATING TIP TROCAR NONE GCJ ETHICON ENDO-SURGERY, LLC NA D4JX2A

    Patients

    Seq Age Sex Outcome Treatment
    1