BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12114666 · Received July 4, 2021

    Report

    Report Number
    9610877-2021-10040
    Event Type
    Malfunction
    Date Received
    July 4, 2021
    Date of Event
    May 28, 2021
    Report Date
    July 31, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO DUST IN THE UNIT. IN ADDITION, WE CONFIRMED THAT THE RIS UNIT MALFUNCTION, THE PROCESS BOARD NTSC MALFUNCTION, AND THE SCOPE LOCKING STRUCTURE BREAK; HOWEVER, THERE ARE NOT RELATED TO THE ALLEGED COMPLAINT. IT HAS NOT BEEN REOCCURRED THE SAME PROBLEM AFTER REPLACING THE UNIT AT THE END OF MAY. WE WILL KEEP TO MONITOR THE MARKET QUALITY. CORRECTION INFORMATION: G6: FOLLOW UP #1 H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT:COMPONENT CODE AND TYPE OF INVESTIGATION. ADDITIONAL INFORMATION: H6: CODING ADDED BASED ON THE INVESTIGATION RESULT:INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. IT WAS RE-OCCURRED THE SAME FAILURE AFTER THE PREVIOUS REPAIR. FROM A DESCRIPTION ON THE COMPLAINT, IT MIGHT BE CAUSED DUE TO THE LAMP DEFECT OR DUST IN THE LIGHT SOURCE. DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EPK-3000, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. THE DEVICE WAS RETURNED, BUT IT'S STILL UNDER INVESTIGATION,SO THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SAME FAILURE AS THE PREVIOUS REPAIR HAS OCCURRED AND HAS NOT BEEN FIXED. (B)(6) 2020: IMMEDIATELY AFTER REPLACING THE LAMP, I STARTED TO USE THE AUXILIARY LIGHT FREQUENTLY. (B)(6) 2020: LAMP NOT LIT BEFORE INSPECTION 03-4000 ERROR LOG TROUBLE OCCURRED. REPLACEMENT OF SUBSTITUTES. LAMP DOOR CHANGED AND LAMP POWER SUPPLY DUST COUNTERMEASURES IMPLEMENTED FOR COMPLAINT REPAIR. (B)(6) 2020: LAMP GOES OUT BEFORE INSPECTION 03-1000 ERROR LOG TROUBLE OCCURRED. REPLACEMENT OF SUBSTITUTES. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011479 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1