BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 14139556 · Received April 19, 2022

    Report

    Report Number
    9610877-2022-52722
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 19, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 SEGMENT STEEL BRAID STEEL BRAID PIERCING . BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE SEGMENT STEEL BRAID. IN ADDITION, WE CONFIRMED THAT THE BENDING RUBBER LEAK; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0628(IFT)"" 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. INSERTION FLEXIBLE TUBE (IFT) STEEL BRAID PIERCING .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620565 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown