BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12291785 · Received August 6, 2021

    Report

    Report Number
    9610877-2021-00389
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 13, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: PENTAX MODEL ED-3490TK IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. 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? H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT (HEALTH EFFECT - CLINICAL CODE, 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, " THE SCOPE IS HAVING AN ISSUE OF PRODUCING BLACK IMAGES" INVOLVING PENTAX MODEL ED-3490TK/SERIAL (B)(4). NO FURTHER INFORMATION WAS PROVIDED. PENTAX HAS MADE 3 GOOD FAITH EFFORT ATTEMPTS TO COLLECT ADDITIONAL INFORMATION FROM THE FACILITY. THE FACILITY CONTACT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO PENTAX. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, DISTAL TIP ANNUAL MAINTENANCE, UP/ DOWN ANGULATION TIGHT, RIGHT/ LEFT ANGULATION TIGHT. IMAGE BLACKOUT, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, #4 REMOTE CONTROL BUTTON NOT WORKING, #3 REMOTE CONTROL BUTTON NOT WORKING, #2 REMOTE CONTROL BUTTON NOT WORKING, #1 REMOTE CONTROL BUTTON NOT WORKING, RIGHT/ LEFT BRAKE KNOB RETAINING NUT COVER CRACKED, UP/ DOWN BRAKE KNOB/ LEVER SCRATCHED, RIGHT/ LEFT LOCK UNIT BROKEN. THE CUSTOMER COMPLAINT WAS CONFIRMED. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: OPERATION CHANNEL, ELECTRICAL CONNECTOR ASSY, PCB FOR CCD K2 PB-FREE/NTSC, O-RING(0.5X1.3) IMP-1, BENDING RUBBER, DISTAL CASE/CAP, O-RINGS AND SEALS, X-RING(1.8X19.6) GRAY, UD LOCK LEVER, RL LOCK KNOB RETAINING NUT COVER, SHIELD PIPE FOR CCD, LASER CUT FILTER TYPE 7, OBJECTIVE PRISM ASSY, RL LOCK BASE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185974 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown