BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19526165 · Received June 13, 2024

    Report

    Report Number
    9610877-2024-54488
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 13, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K172156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD SIGNAL WIRE RUPTURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD SIGNAL WIRE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LIGHT GUIDE CABLE COATING DAMAGE, THE LIGHT GUIDE CABLE FOR CONTROL BODY COATING DAMAGE, THE LIGHT GUIDE CABLE FOR PRONG COATING DAMAGE, THE SEGMENT BROKEN, THE INSERTION FLEXIBLE TUBE PERFORATED, THE REMOTE CONTROL BUTTONS PERFORATED, AND THE BENDING RUBBER STRETCHED; 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 NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794274 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL8-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown