BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 13519400 · Received February 13, 2022

    Report

    Report Number
    9610877-2022-00158
    Event Type
    Injury
    Date Received
    February 13, 2022
    Date of Event
    January 14, 2022
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333237869
    PMA / PMN Number
    K190805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. SIMILAR MODEL EC38-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. (B)(4). THE DEVICE IS PENDING RETURN FOR FURTHER EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G4:PREMARKET IDENTIFICATION PMA/510(K). G6: FOLLOW UP #1. H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: D4:UNIQUE IDENTIFIER (UDI). H4:DEVICE MANUFACTURE DATE. EVALUATION SUMMARY: WHEN THE ANGLE OF THE SCOPE WAS TIGHT, ESPECIALLY WHEN USING THE COLONOSCOPE, GRINDING OCCURRED DURING THE PROCEDURE, CAUSING PAIN IN THE USER'S HAND. THE PROBABLE CAUSE IS THE BURDEN ON THE USER DUE TO ANGLE MANIPULATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX ENDOSCOPE MODEL EC38-I10CL. IN THE EVENT REPORTED, THE DOCTORS ARE COMPLAINING OF SCOPE TIGHT/GRINDING, CAUSING PAIN TO THEIR HANDS. THE EVENT TIMING IS IN THE PROCEDURE ROOM DURING USE. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90452 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CL 04961333237869

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other