BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 14422955 · Received May 17, 2022

    Report

    Report Number
    9610877-2022-53101
    Event Type
    Injury
    Date Received
    May 17, 2022
    Date of Event
    April 22, 2022
    Report Date
    October 12, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE WATER JET TUBE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY ON THE WATER JET TUBE. IN ADDITION, WE CONFIRMED THAT THE NOZZLE GLUING MISSING, THE BENDING RUBBER DISCOLORED, THE SUCTION CHANNEL KINK, AND THE ANGLE WIRE GRINDING; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0630 (AIR/WATER & JET WATER CHANNELS)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: IT WAS REPORTED TO CUSTOMER SERVICE DURING USE OF THE COLONOSCOPE ABOVE THE USER WAS NOT ABLE TO PRESSURE DOWN ON THE WATER JET AND LED TO DAMAGED MUCOSA. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE WATER JET TUBE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY ON THE WATER JET TUBE. CORRECTION INFORMATION: B2: OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. B5: DESCRIBE EVENT OR PROBLEM. G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: G4: PMA/510(K). H1: TYPE OF REPORTABLE EVENT. H4: DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.

    Description of Event or Problem · 0

    ADVERSE EVENT - DAMAGED MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230842 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other