BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15705638 · Received November 1, 2022

    Report

    Report Number
    9610877-2022-59249
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 1, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 VNL-1570STK IS AVAILABLE IN THE USA WITH A 510K NUMBER K162151. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE LENS UNIT CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE LENS UNIT. IN ADDITION, WE CONFIRMED THAT THE U/D LOCK LEVER BROKEN, THE REMOTE CONTROL BUTTONS PERFORATED, THE INSERTION FLEXIBLE TUBE (IFT) CRUSHED, THE SEGMENT CRUSHED, THE LIGHT GUIDE CABLE FOR CONTROL BODY DEFORMED, THE REMOTE CONTROL BUTTONS LEAK, THE REMOTE CONTROL BUTTONS CUT, AND THE INSERTION FLEXIBLE TUBE (IFT) BUMP; HOWEVER, THEY ARE 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(CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462497 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown