BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12923317 · Received December 3, 2021

    Report

    Report Number
    9610877-2021-01574
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 5, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: REPEATED USE CAUSES THE CABLE TO BREAK OFF. CORRECTION INFORMATION: G4: PREMARKET IDENTIFICATION PMA/510(K). G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: H3: DEVICE EVALUATED.

    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. PENTAX ISSUED RMA (B)(4) FOR THE DEVICE TO BE RETURN FOR FURTHER EVALUATION. THE DEVICE IS CURRENTLY PENDING RETURN. ON 11-NOV-2021, 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 23-SEP-2013 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.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX VIDEO SCOPE EC38-I10L. IN THE EVENT REPORTED, THE USER STATED THERE WAS NO VIDEO IMAGE. THE TIMING OF THE EVENT IS UNKNOWN. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824277 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown