BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR

    MDR report key: 8366862 · Received February 25, 2019

    Report

    Report Number
    3005075853-2019-16836
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Report Date
    January 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    UDI-DI
    10705036001188
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION, FAP MECHANISM BECAME NOT FUNCTION DURING USE, AND THERE WAS A DIFFICULTY IN INSERTING EQUIPMENT TO BE USED TOGETHER. FAP MECHANISM WAS RETURNED MANUALLY. THE FAP IS A FUNCTION OF THE DEVICE. THE DRAG FORCE IS GETTING LOW DURING THE OPERATION. HE MENTIONED THE INNER SEAL ASSEMBLY DID NOT BACK TO CENTER POSITION, SO HE NEED TO BACK THE SEAL TO CENTER POSITION MANUALLY IN ORDER TO INSERT ECHELON. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162015 ENDOPATH XCEL BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. 10705036001188

    Patients

    Seq Age Sex Outcome Treatment
    1