BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT

    MDR report key: 8203076 · Received December 28, 2018

    Report

    Report Number
    9612501-2018-02307
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 3, 2018
    Report Date
    April 1, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521657687
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 CIRCULAR SEAL WAS STRETCHED. THE TROCAR AND CANNULA APPEARED INTACT. THE OBTURATOR WAS RECEIVED. THE ENVELOPE SEAL WAS STRETCHED OUT. THE OBTURATOR WAS RECEIVED INSERTED INTO THE CANNULA. PROLONGED INSERTION CAN CAUSE THE ENVELOP SEAL TO BECOME STRETCHED. THE STOPCOCK WAS INTACT. PMV PERFORMED FUNCTIONAL TESTING; THE DEVICE FAILED AN AIR LEAK TEST. 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 GASTRIC BYPASS, THE TROCAR LEAKED CARBON DIOXIDE THROUGHOUT THE CASE. THE SEAL DID NOT FUNCTION PROPERLY. THE SURGEON WORKED THROUGH THE ISSUE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042175 VERSAPORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD ONB12STF J8G2131JX 10884521657687

    Patients

    Seq Age Sex Outcome Treatment
    1