BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 8121094 · Received November 30, 2018

    Report

    Report Number
    9612501-2018-02151
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 7, 2018
    Report Date
    March 11, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521539853
    PMA / PMN Number
    K151548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 NOTED: THE CIRCULAR SEAL WAS CUT. THE TROCAR, CANNULA AND DUCKBILL SEAL APPEARED INTACT. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE PASSED 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. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE CUT IN THE CIRCULAR SEAL MAY OCCUR WHEN MISHANDLED DURING CLINICAL APPLICATION. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. NO RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT WAS CONFIRMED. 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 CHOLECYSTECTOMY, THERE WAS A LITTLE PIECE OF BLUE FABRIC, FROM THE SEAL. THE FABRIC FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958345 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD B11STF J8D0012X 10884521539853

    Patients

    Seq Age Sex Outcome Treatment
    1