BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19188958 · Received April 26, 2024

    Report

    Report Number
    9610877-2024-53081
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 18, 2024
    Report Date
    April 26, 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
    PHYSICIAN
    Health Professional
    Yes

    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 MODULE WITH DRIVE PCB SHADOW IN IMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB DISTAL COVER GLASS CRACKED, THE INSERTION FLEXIBLE TUBE CRUSHED, AND THE REMOTE CONTROL BUTTONS 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(SHADOW IN IMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126445 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL8-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown