BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT

    MDR report key: 7919747 · Received September 28, 2018

    Report

    Report Number
    9612501-2018-01749
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 7, 2018
    Report Date
    March 21, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    20884521215396
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE TROCAR AND CIRCULAR SEAL APPEARED INTACT. ONLY THE TROCAR WAS RECEIVED. PMV PERFORMED FUNCTIONAL TESTING; THE TROCAR WAS DISASSEMBLED TO MEASURE WELD HEIGHT, THE WELD HEIGHT WAS IN SPEC. (.250 +/- .005). RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEPATECTOMY, WHILE CLIPPING THE VESSEL, THE TROCAR SEAL DISENGAGED AND WAS DAMAGED. THEY OPENED NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761504 VERSAPORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD UNVCA12STF J6H1738X 20884521215396

    Patients

    Seq Age Sex Outcome Treatment
    1