BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS

    MDR report key: 3840463 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03671
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 8, 2014
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS A DUPLICATE OF 3005075853-2014-02814. THIS COMPLAINT IS BEING VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4); DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM PROCEDURE; THE SMALL BLACK VALVE OF TROCAR BROKE AND WAS LEFT IN PATIENT. SURGEON WAS ABLE TO REMOVE VALVE MANUALLY. ALL OTHER PARTS OF TROCAR WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318732 ENDOPATH** XCEL* BLADELESS LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4CF35

    Patients

    Seq Age Sex Outcome Treatment
    1