BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 15693147 · Received October 28, 2022

    Report

    Report Number
    2518897-2022-00214
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    April 22, 2022
    Report Date
    October 28, 2022
    Manufacturer
    HOYA CORPORATION PENTAX
    Product Code
    FDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MODEL IS CLASSIFIED AS IMPORT FOR EXPORT AND NOT DISTRIBUTED IN THE UNITED STATES, THEREFORE 510K IS NOT APPLICABLE. WE DO HAVE SIMILAR MODEL EC38-I10L-US AVAILABLE IN THE UNITED STATES WITH A 510K NUMBER K131855. INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING (B)(4). THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 22-APR-2022. THE ENDOSCOPE WAS RETURNED AND INSPECTED BY PENTAX MEDICAL SERVICE. IT WAS CONFIRMED THAT ON THE RETURNED UNIT THE WATER JET TUBE WAS CLOGGED. BASED ON THE EVALUATION, IT WAS CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY ON THE WATER JET TUBE. ADDITIONALLY. IT WAS CONFIRMED THAT NOZZLE GLUE IS MISSING, THE BENDING RUBBER IS DISCOLORED, THE SUCTION CHANNEL IS KINKED, AND THE ANGLEWIRE IS GRINDING; HOWEVER, THEY ARE NOT THE MAIN CAUSE OF, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THE DEVICE WAS REPAIRED . IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, THE CUSTOMER INITIALLY REPORTED NOT BEING ABLE TO TURN PRESSURE DOWN ON THE WATER JET INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4). ON (B)(6) 2022, PENTAX MEDICAL INC. WAS NOTIFIED OF THE ESCALATION OF THE EVENT TO AN ADVERSE EVENT AS THE PATIENT EXPERIENCED MUCOSAL DAMAGE DURING THE PROCEDURE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796083 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other