BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT

    MDR report key: 8545635 · Received April 24, 2019

    Report

    Report Number
    9612501-2019-00856
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 13, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521215399
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    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, CANNULA AND ENVELOPE SEAL AND CIRCULAR SEAL APPEARED INTACT. PMV PERFORMED FUNCTIONAL TESTING; THE DEVICE PASSED AN AIR LEAK TEST. THE ENVELOPE SEAL PASSES HOWEVER THE INSTRUMENT SEAL LEAKS DURING MANUAL MANIPULATION USING AN ENDO PEANUT. 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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AT THE START OF THE SURGERY THE TWO REPORTED DEVICE HAD AIR OR GAS LEAKED FROM THE SEAL. THE DEVICE SEAL WAS PHYSICALLY BROKEN. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336757 VERSAPORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD UNVCA12STF J8G0836X 10884521215399

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR