BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 14230488 · Received April 28, 2022

    Report

    Report Number
    9610877-2022-00499
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    February 24, 2022
    Report Date
    January 15, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333237654
    PMA / PMN Number
    K190805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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. MODEL EC34-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 24-MAR-2022.. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER WORK ORDER (B)(4) AND THE TECHNICIAN CONFIMED THE CUSTOMER COMPLAINT AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: CUSTOMER COMPLAINT FINDINGS: CUSTOMER COMPLAINT DUPLICATE, SCOPE ELECTRICAL TEST FUNCTION: DST ELECTRICAL SAFETY TEST PASS, SCOPE ELECTRICAL TEST FUNCTION: PLCT ELECTRICAL SAFETY TEST PASS, SCOPE LEAK TEST FUNCTION: DRY LEAK TEST PASS, SCOPE LEAK TEST FUNCTION: WET LEAK TEST PASS, LIGHT EMITTING DIODE(LED): LED BLACKOUT, AIR/WATER SOCKET: CHIPPED/CUT O-RING. THE DEVICE WILL UNDERGO REPAIRS AND BE RETURNED TO THE CUSTOMER ONCE COMPLETED. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS OF 26-APR-2022.. THIS IS THE FIRST TIME MODEL EC34-I10CL, SERIAL NUMBER (B)(4) HAS BEEN RETURNED TO THE PENTAX MONTVALE FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. THE INVESTIGATION IS IN-PROCESS. 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: THIS EVENT IS CONSIDERED TO BE CAUSED BY AN EXTERNAL LOAD CAUSING THE IMAGE TO DISAPPEAR DUE TO AN ABNORMALITY IN AN ELECTRICAL COMPONENT, DISCONNECTION OF AN ELECTRIC WIRE, OR THE LIKE. DEVICE HAS BEEN REPAIRED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A COMPLAINT ON 22-MAR-2022 THAT OCCURRED IN AN OPERATING ROOM DURING USE IN (B)(6) WITHIN THE PAI REGION. THE CUSTOMER INITIALLY REPORTED FOG TEST FAILURE. THE IMAGE DISAPPEARED DURING PATIENT PROCEDURE WHEN CONTROL KNOBS WERE APPLIED. ON (B)(6) 2022, A PENTAX SALES REP HAD A PHONE CALL WITH THE USER FACILITY AND THE FACILITY HAD INTERMITTENT BLACK OUTS AND THE DOCTOR LOST VISIBILITY WHILE DOING THE EXAM. DURING ONE PARTICULAR CASE THIS HAPPENED RIGHT AFTER THE DOCTOR REMOVED A POLYP AND WAS CAUTERIZING THE IT. THE DOCTOR WAS NOT ABLE REGAIN VISIBILITY AND WAS CONCERNED THAT THE PATIENT MIGHT HAVE INTERNAL BLEEDING AS A RESULT OF THE POLY REMOVAL. DURING GOOD FAITH EFFORT ATTEMPTS ON (B)(6) 2022, THE PAI CHU WAS PROVIDED TWO ENDOSCOPES AS THE POTENTIAL ENDOSCOPE USED DURING THE LOSS OF IMAGE DURING CAUTERIZING CASE. DUE TO THE REPORTED BLEEDING AND POTENTIAL OF INTERNAL BLEEDING RELATED TO THE MALFUNCTION, PENTAX MEDICAL WILL BE FILING TWO EVENTS TO THE FDA, ONE FOR EACH OF THE MODEL AND SERIALS PROVIDED, WITH A REPORTABLE EVENT AWARENESS DATE OF 01-APR-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741269 PENTAX IMAGINA COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC34-I10CL 04961333237654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other