BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12291329 · Received August 6, 2021

    Report

    Report Number
    9610877-2021-00388
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    November 2, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333146208
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #1, H2:IF FOLLOW-UP, WHAT TYPE?, H3:DEVICE EVALUATED BY MANUFACTURE, H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT (HEALTH EFFECT - CLINICAL, HEALTH EFFECT - IMPACT CODE). ADDITIONAL INFORMATION: H4:DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, "NO VIDEO IMAGE" INVOLVING PENTAX MODEL EC-3490LI/SERIAL (B)(4). NO FURTHER INFORMATION WAS PROVIDED. PENTAX HAS MADE 3 GOOD FAITH EFFORT ATTEMPTS TO COLLECT ADDITIONAL INFORMATION FROM THE FACILITY. A RESPONSE WAS RECEIVED WHERE THE FACILITY CONTACT STATED THERE IS NOTHING MORE TO REPORT ON THIS ISSUE. THE DEVICE WAS RETURNED TO PENTAX. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: UMBILICAL CABLE SINGLE MULTIPLE BUMPS, INSERTION TUBE BUMP AT END OF ROOT BRACE, SUCTION TUBE RESISTANCE, INSERTION TUBE BUMP AT END OF ROOT BRACE, CONTROL BODY GRIP SCRATCHED, WATER SUPPLY TUBE SHORT, AIR SUPPLY TUBE SHORT, PVE CONNECTOR HOUSING SCRATCHED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, SUCTION CHANNEL LG, LIGHT GUIDE CABLE, PCB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY, X-RING, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188028 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3490LI 04961333146208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown