BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16040938 · Received December 23, 2022

    Report

    Report Number
    9610877-2022-61467
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 23, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASS1 PRODUCT SO THAT 510K# IS BLANK. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE ANGLE WIRE BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE ANGLE WIRE. IN ADDITION, WE CONFIRMED THAT THE LIGHT GUIDE CABLE BUCKLED, THE REMOTE CONTROL BUTTONS CRACKED, THE INSERTION FLEXIBLE TUBE (IFT) CRUSHED, AND THE ANGULATION-DOWN ANGULATION ZERO DEGREES; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. AS A RESULT OF CONFIRMING THE DETAIL AS GFE, NO RESPONSE WAS OBTAINED, SO WE CANNOT DENY THE POSSIBILITY OF THE ANGLE STUCK OCCURRED IN THE HUMAN BODY. THEREFORE, BASED ON THE TECHNICAL REPORT "HR-RPT-0587(ANGLE)" 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. ANGLE WIRE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726074 PENTAX VIDEO LARYNGOSTROBOSCOPE (SLIM) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown