BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16792945 · Received April 23, 2023

    Report

    Report Number
    9610877-2023-53744
    Event Type
    Malfunction
    Date Received
    April 23, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 24, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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 DRIVE PCB DISCONNECTED WIRES. 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 SEGMENT FLUID DAMAGE, THE ROOT BRACE RUBBER (LG CONTROL BODY) CRACKED, THE ANGLE WIRE PLAY, THE NOZZLE GLUING MISSING, THE WATER NOZZLE DEFORMED, THE WATER TUBE LEAK, THE LG WATER SUPPLY TUBES LEAK, THE LG AIR SUPPLY TUBES LEAK, THE JUNCTION CASE SCRATCHED, THE OBJECTIVE LENS SCRATCHED, THE LCB DISTAL COVER GLASS DIRTY, THE BENDING RUBBER GLUING BUBBLING, AND THE SEGMENT STEEL BRAID RUPTURE; 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
    1566373 PENTAX VIDEO GASTROSCOPE 2.8C 9.8T 1050L FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown