BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16917017 · Received May 12, 2023

    Report

    Report Number
    9610877-2023-54207
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 12, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 BODY CHIPPED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE DISTAL BODY. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE REMOTE CONTROL BUTTONS PERFORATED, THE INSERTION FLEXIBLE TUBE BUCKLED, THE LIGHT GUIDE CABLE BUCKLED, THE CONTROL BODY CRACKED, AND THE U/D KNOB WHITE MARKING FADED/MISSING; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. IN TERMS OF THE DISTAL BODY CHIPPED, THE POSSIBILITY OF DROPPING INTO HUMAN BODY COULD NOT BE DENIED. MOREOVER, BASED ON THE TECHNICAL REPORT""HR-RPT-0974(DISTAL END)"" 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. DISTAL CASE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475645 PENTAX VIDEO CYSTOSCOPE FAJ HOYA CORPORATION PENTAX TOKYO OFFICE ECY-150S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown