BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* XCEL TROCAR

    MDR report key: 1910063 · Received November 30, 2010

    Report

    Report Number
    1527736-2010-00112
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: TORQUE APPLIED THE COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC PROCEDURE, THE DEVICE CAUSED INSUFFLATION ISSUES. ISSUE WAS NOTICED WITH THE CAMERA PORT. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. IT IS UNKNOWN HOW CASE WAS COMPLETED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1