BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12629660 · Received October 14, 2021

    Report

    Report Number
    9610877-2021-50057
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 14, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DISTAL BODY SCRATCHED, CCD MODULE CLOUDY, INSERTION FLEXIBLE TUBE (IFT) BUCKLED, REMOTE CONTROL BUTTONS PERFORATED, REMOTE CONTROL BUTTONS PERFORATED, U/D LOCK LEVER CRACKED, LIGHT GUIDE CABLE BUCKLED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE CCD MODULE CLOUDY; HOWEVER, OTHER FAILURE IS NOT RELATED TO THE ALLEGED COMPLAINT.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527535 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1