BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12 MM DIAMETER,100MM LENGTH

    MDR report key: 1210268 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02480
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    October 9, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/21/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A VIDEO LAPAROSCOPIC BARIATRIC PROCEDURE. DURING USE OF THE DEVICE, LEAKAGE WAS OBSERVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12 MM DIAMETER,100MM LENGTH GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1