BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 9430519 · Received December 6, 2019

    Report

    Report Number
    9612501-2019-02342
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    October 4, 2019
    Report Date
    March 31, 2020
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521546882
    PMA / PMN Number
    K151548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 CIRCULAR SEAL, TROCAR AND CANNULA APPEARED INTACT. THE OBTURATOR WAS RECEIVED. THE STOPCOCK WAS INTACT. A FUNCTIONAL EVALUATION FOUND THAT 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. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. 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 PROCEDURE, SEAL OF THE TROCAR WAS PHYSICALLY DAMAGED AND AN AIR OR GAS LEAK WAS NOTED FROM THE SEAL. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215926 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD NONB12STF J8F1108X 10884521546882

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR