BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15436101 · Received September 16, 2022

    Report

    Report Number
    9610877-2022-57988
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 16, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 VNL11-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE DISTORTED IMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. IN ADDITION, WE CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) DENTED; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0586(IMAGE FAILURE)" 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. VIDEO IMAGE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124227 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown