BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11382409 · Received February 25, 2021

    Report

    Report Number
    9610877-2021-00036
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Report Date
    January 26, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    D304562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TYPE OF INVESTIGATION: 10 TESTING OF ACTUAL/SUSPECTED DEVICE.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE ON 26-JAN-2021 OF AN EVENT THAT OCCURRED IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE AIR/WATER NOZZLE IS MISSING, INVOLVING THE PENTAX MEDICAL VIDEO COLONOSCOPE, MODEL EC38-I10L, SERIAL NUMBER (B)(4). NO PATIENT INVOLVEMENT WAS REPORTED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 29-JAN-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT THAT THE WATER NOZZLE MISSING AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 03-FEB-2021: SUCTION TUBE RESISTANCE, DISTAL BODY ABRASION, BENDING RUBBER GLUE CRACKING AT DISTAL SIDE, BENDING RUBBER GLUE CRACKING AT INSERTION TUBE SIDE, FAILED DRY LEAK TEST, # 1 REMOTE CONTROL BUTTON COVER CRACKED, BENDING RUBBER MILD DISCOLORATION, AIR NOZZLE GLUE WORN, LEAK AT # 1 REMOTE CONTROL BUTTON COVER, FAILED WET LEAK TEST. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, DISTAL END ASSY WITH TUBES, BENDING RUBBER, RL PULLEY ASSY, UD PULLEY ASSY, ADJUSTING COLLAR, ANGLE WIRE, REMOTE CONTROL BUTTON(1), SUCTION CHANNEL LG, O-RING (1.8X19.8). MODEL EC38-I10L, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2018. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVED BY FINAL QC AS OF 25-FEB-2021. INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278624 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1