BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18390797 · Received December 26, 2023

    Report

    Report Number
    9610877-2023-62462
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    December 13, 2023
    Report Date
    December 26, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASS1 PRODUCT SO THAT 510K# IS BLANK. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD DRIVE PCB AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE UP PULLEY WIRE FLUID DAMAGE, THE LEFT PULLEY WIRE FLUID DAMAGE, THE LIGHT GUIDE CABLE COATING DAMAGE, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE INSERTION FLEXIBLE TUBE BUCKLED, THE CONTROL BODY CORRODED, THE CCD DRIVE PCB CORRODED, THE ELECTRICAL PIN CONNECTOR CORRODED, THE LG CONNECTOR CORRODED, THE BENDING RUBBER LEAK, THE REMOTE CONTROL BUTTONS LEAK, THE BENDING RUBBER CUT, THE REMOTE CONTROL BUTTONS CUT, THE ELECTRICAL PIN CONNECTOR DIRTY, AND THE SEGMENT WORN OUT; HOWEVER, THESE DEFECTS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263976 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown