BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12207120 · Received July 21, 2021

    Report

    Report Number
    9610877-2021-00250
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A COMPLAINT TO CUSTOMER SERVICE ON 21-JUN-2021 FOR A "NO VIDEO IMAGE" THAT OCCURRED IN THE UNITED STATES INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC38-I10L, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO GOOD FAITH EFFORT(GFE) EMAILS VIA EMAIL ON 30-JUN-2021 AND CONFIRMED THE NO VIDEO IMAGE OCCURRED DURING PRE-INSPECTION CHECK AND THE ENDOSCOPE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 28-JUN-2021. THE COLONOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER 3134002 AND THE TECHNICIAN IDENTIFIED "IMAGE DISTORTED" AS WELL DOCUMENTING THE FOLLOWING INSPECTION FINDINGS ON 29-JUN-2021: OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, WATER NOZZLE GLUE WORN, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, SUCTION TUBE RESISTANCE, AIR NOZZLE GLUE WORN, FLUID INVASION IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION. THE DEVICE UNDERWENT REPAIRS FOR THE SLICE IN THE CHANNEL AND FLUID INVASION INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, RL PULLEY ASSY, UD PULLEY ASSY, ADJUSTING COLLAR, ANGLE WIRE, SUCTION CHANNEL LG, OPERATION CHANNEL, PCB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY, BODY COVER GRIP, SIDE BODY COVER TRIM CAP, SIDE BODY COVER ATTACHING SCREW. THIS IS THE FIRST TIME PENTAX MODEL EC38-I10L, SERIAL NUMBER (B)(4) HAS BEEN RETURNED FOR SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 23-MAY-2018. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 19-JUL-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103678 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1