BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 14460089 · Received May 20, 2022

    Report

    Report Number
    9610877-2022-00507
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 21, 2022
    Report Date
    December 1, 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
    CT, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: 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: H4:DEVICE MANUFACTURE DATE. EVALUATION SUMMARY: AFTER COMPLETING THE ACCEPTANCE INSPECTION, IT WAS FOUND THAT THERE WAS FLUID INTRUSION INSIDE THE LOCATION OF THE PVE CONNECTOR. WE DID A GOOD FAITH EFFORT THREE TIMES BUT DID NOT RECEIVE A REPLY FROM THE HOSPITAL. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CMOS-M WITH DRIVE PCB AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CMOS-M WITH DRIVE PCB. IN ADDITION, WE CONFIRMED THAT THE CMOS-M WITH DRIVE PCB FLUID DAMAGE, THE LG CABLE CONNECTOR FLUID DAMAGE, THE OBJECTIVE LENS UNIT CRACKED, AND THE LG CABLE CONNECTOR CORRODED.

    Additional Manufacturer Narrative · 0

    G4:. PREMARKET IDENTIFICATION PMA/510(K), G6: FOLLOW UP #2, H2: IF FOLLOW-UP, WHAT TYPE?

    Description of Event or Problem · 0

    CUSTOMER REPORTED ON (B)(6) 2022, AN EC38-I10CL BROUGHT UP A MESSAGE STATING "SCOPE NOT SUPPORTED" AND THEN THE LIGHTS WENT OUT DURING A PROCEDURE. PATIENT ON TABLE WAS WOKEN FROM ANESTHESIA, AND PUT BACK UNDER WHILE PROBLEM WAS ADDRESSED. THE ACCOUNT TRIED PLUGGING THE SCOPE INTO 3 OTHER PROCESSORS, BUT COULD NOT GET THE LIGHTS TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523385 PENTAX IMAGINA COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CL 04961333237869

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other