BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12249449 · Received July 29, 2021

    Report

    Report Number
    9610877-2021-00366
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 1, 2021
    Report Date
    December 6, 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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT. EVALUATION SUMMARY: THIS IS AN EVENT, IN WHICH A FOREIGN MATTER SUCH AS A BRUSH CLOGS THE PIPE. THE CAUSE IS THOUGHT TO BE, THAT THE BRUSH USED BY THE USER, DURING CLEANING WAS BROKEN AND REMAINED IN THE PIPE. PENTAX HAS ADDED A METHOD FOR ALERTING AND DETECTING IN IFU IN THE EVENT, AND ALSO IMPLEMENTED FIELD ACTION. THE EVENT WAS NOT A CLOGGED FOREIGN OBJECT THAT WAS UNKNOWINGLY USED ON THE NEXT PATIENT, BUT WAS SUCCESSFULLY DETECTED. AND A COMPLAINT WAS REPORTED.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, " XOGRAPH MODEL BRUSH CS5522A/LOT 0042101 WAS BEING USED TO REPROCESS EC-3490LI/SERIAL (B)(4); BRUSH WAS INTRODUCED INTO THE CONTROL BODY CYLINDER AND THE TECH NOTICED THAT THE BRUSH WAS VERY EASY TO PULL OUT AND THAT WHEN ALL THE WAY OUT, THE BRUSH WAS MISSING. SO, THE TECH PUT IN ANOTHER BRUSH AND FOUND THAT THE RESISTANCE WAS ABOUT 3 TO 4 INCHES INTO THE CONTROL BODY. ANOTHER BRUSH WAS ADVANCED, AND THE BROKEN BRUSH WAS ABLE TO BE RETRIEVED. SCOPE PASSED WET AND DRY LEAK TESTS." NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED TO PENTAX ON 07/13/2021. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: GROUND WIRE DISCONNECTED, PASSED WET/DRY LEAK TESTS, UMBILICAL CABLE ABRASION, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, FLUID INVASION NOT OBSERVED IN CONTROL BODY NOR IN PVE CONNECTOR. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS. THE DEVICE HAS BEEN ROUTINELY SERVICED BY PENTAX SINCE INSTALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141609 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3490LI 04961333146208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown