BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12818250 · Received November 16, 2021

    Report

    Report Number
    9610877-2021-50382
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    November 11, 2021
    Report Date
    November 16, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL VNL-1570STK IS AVAILABLE IN THE USA WITH A 510K NUMBER K162151. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD MODULE . IN ADDITION, WE CONFIRMED THAT THE CONTROL BODY COMPLETE FLUID DAMAGE, THE LIGHT GUIDE CABLE SCRATCHED, THE LIGHT GUIDE CABLE BUCKLED, THE INSERTION FLEXIBLE TUBE (IFT) BROKEN, AND THE INSERTION FLEXIBLE TUBE (IFT) LEAKY; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT 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. FIBER IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722618 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown