BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13306425 · Received January 20, 2022

    Report

    Report Number
    9610877-2022-00110
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 21, 2021
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. THE DEVICE WAS RECEIVED AT PENTAX MEDICAL ON SERVICE ORDER 6181059 FOR FURTHER EVALUATION. THE DEVICE IS CURRENTLY PENDING EVALUATION. ON 05-JAN-2022, A DEVICE HISTORY RECORD (DHR) REVIEW FOR MODEL EC38-I10L, SERIAL NUMBER (B)(4) WAS PERFORMED AND THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 24SEP2014 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE CUSTOMER REPORTED RESISTANCE IN THE PRIMARY BIOPSY CHANNEL. THE PRESUMED CAUSE WAS THAT THE INTERNAL ASPIRATION LINE BUCKLED AS A RESULT OF FLEXING THE INSERTION SECTION OF THE ENDOSCOPE. CORRECTION INFORMATION: G4: PREMARKET IDENTIFICATION. G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: H3: DEVICE EVALUATED.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX ENDOSCOPE SCOPE MODEL EC38-I10L. IN THE EVENT REPORTED, THE USER STATED THERE WAS RESISTANCE IN PRIMARY BIOPSY CHANNEL. THE EVENT TIMING IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT. THIS EVENT MEETS THE REQUIREMENT FOR FDA REPORTABILITY; THEREFORE, SUBMISSION OF A 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
    507759 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown