BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19113569 · Received April 16, 2024

    Report

    Report Number
    9610877-2024-52868
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 16, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE DISTAL END WITH CCD MODULE FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE DISTAL END WITH CCD MODULE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, THE LIGHT GUIDE CABLE COATING DAMAGE, THE LIGHT GUIDE CABLE FOR CONTROL BODY COATING DAMAGE, THE LIGHT GUIDE CABLE FOR PRONG COATING DAMAGE, THE INSERTION FLEXIBLE TUBE PERFORATED, THE REMOTE CONTROL BUTTONS PERFORATED, THE LIGHT GUIDE CABLE FOR CONTROL BODY PERFORATED, THE INSERTION FLEXIBLE TUBE BUCKLED, THE LIGHT GUIDE CABLE BUCKLED, THE CONTROL BODY CRACKED, THE BENDING RUBBER STRETCHED, AND THE ROOT BRACE RUBBER (LG CONNECTOR) CUT; 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(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582203 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-110STS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown