BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13201424 · Received January 9, 2022

    Report

    Report Number
    9610877-2022-00024
    Event Type
    Malfunction
    Date Received
    January 9, 2022
    Report Date
    October 31, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MODEL IS CLASSIFIED AS IMPORT FOR EXPORT AND NOT DISTRIBUTED IN THE UNITED STATES, THEREFORE 510K IS NOT APPLICABLE. WE DO HAVE SIMILAR MODEL EC38-I10L-US AVAILABLE IN THE UNITED STATES WITH A 510K NUMBER K131855. INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING (B)(4). TYPE OF INVESTIGATION: 10 TESTING OF ACTUAL/SUSPECTED DEVICE. INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 16-DEC-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER 6180820 AND THE WHILE THE TECHNICIAN DID NOT CONFIRM THE CUSTOMER COMPLAINT OF NO VIDEO IMAGE, THEY DID DOCUMENT THE FOLLOWING INSPECTION FINDINGS: IMAGE VIDEO OVERSATURATION BLUE OR GREY DOTS ON EPKI, PASSED DRY LEAK TEST, CUSTOMER COMPLAINT NOT STATED, PASSED WET LEAK TEST, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, UP/ DOWN BRAKE KNOB/ LEVER MARKINGS FADED, CCD CIRCUIT BOARD WRONG MODEL/SERIAL NUMBER INFORMATION, IMAGE GREEN. THE DEVICE WILL UNDERGO REPAIRS AND BE RETURNED TO THE LOANER POOL ONCE COMPLETED. MODEL EC38-I10L, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 16-DEC-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EC38-I10L, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED IN THE (B)(4) ON 29-MAY-2015 UNDER NORMAL CONDITIONS. THE ENDOSCOPE WAS REWORKED FOR A HOLE AT THE TIP. ADHESIVE WAS REPAINTED AND PASSED REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 29-MAY-2015. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED, BUT THE CAUSE COULD NOT BE DETERMINED BECAUSE BASED ON THE INFORMATION OBTAINED AT THIS TIME, IT IS DIFFICULT TO IDENTIFY THE FAILURE PHENOMENON. CORRECTION INFORMATION G6: FOLLOW UP #1. H2: IF FOLLOW-UP, WHAT TYPE? H6: CODING CHANGED BASED ON THE INVESTIGATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. THE INFORMATION PROVIDED INDICATED THAT THERE WAS NO VIDEO IMAGE INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4. THE EVENT WAS OBSERVED IN THE OPERATING ROOM DURING USE. THERE WAS NO REPORT OF PATIENT INJURY, DELAY IN PROCEDURE OR AN EVENT THAT REQUIRED MEDICAL INTERVENTION. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS 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
    2498307 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown