BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16688012 · Received April 6, 2023

    Report

    Report Number
    9610877-2023-53040
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 6, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333129430
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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 DRIVE PCB FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE ELECTRICAL PIN CONNECTOR FLUID DAMAGE, THE LG CONNECTOR FLUID DAMAGE, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE PLUG TO CABLE ATTACHING BASE BROKEN, THE LIGHT GUIDE CABLE BUCKLED, THE ROOT BRACE RUBBER (LG CONNECTOR) CRACKED, THE CCD DRIVE PCB CORRODED, THE ELECTRICAL PIN CONNECTOR CORRODED, THE LG CONNECTOR CORRODED, THE LCB (LIGHT CARRYING BUNDLE) CRUSHED, THE BENDING RUBBER CUT, THE INSERTION FLEXIBLE TUBE CUT, THE ROOT BRACE RUBBER (LG CONNECTOR) CUT, THE U/D AND THE R/L KNOBS LOOSE, THE DISTAL BODY WORN OUT, THE R/L LOCK KNOB HARD TO MOVE, THE U/D LOCK LEVER HARD TO MOVE, THE LG WATER SUPPLY TUBES KINK, THE LG WATER JET SUPPLY TUBES KINK, THE LG AIR SUPPLY TUBES KINK, THE AIR/WATER SOCKET CHIPPED/CUT O-RING, THE LIGHT GUIDE CABLE TWISTED, AND THE SUCTION CHANNEL POWER SUPPLY ISSUES (WIRE CONNECTION); 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
    1853548 PENTAX HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890LI 04961333129430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown