BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15585006 · Received October 12, 2022

    Report

    Report Number
    9610877-2022-58661
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 12, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL VSB-3430K IS AVAILABLE IN THE USA WITH A 510K NUMBER K962897. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE NOZZLE GLUING MISSING. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE NOZZLE GLUING. IN ADDITION, WE CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) LEAK, THE OBJECTIVE LENS UNIT SCRATCHED, THE SEGMENT WORN OUT, AND THE U/D AND THE R/L PULLEY WIRES WORN OUT; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. AS A RESULT OF CONFIRMING THE DETAIL AS GFE, NO RESPONSE WAS OBTAINED, SO WE CANNOT DENY THE POSSIBILITY OF THE GLUE FALLS INTO THE HUMAN BODY. THEREFORE, BASED ON THE TECHNICAL REPORT "HR-RPT-0585 (NOZZLE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2921208 PENTAX VIDEO SMALL BOWEL ENTEROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE VSB-2990I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown