BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 12349277 · Received August 20, 2021

    Report

    Report Number
    2518897-2021-00591
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    May 14, 2021
    Report Date
    August 20, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333248209
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS BEING PROCESSED IN ACCORDANCE WITH DPA-QIP-MDR DECISION BACKLOG MANAGEMENT PLAN. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    THIS MODEL IS NOT DISTRIBUTED IN THE UNITED STATES, THEREFORE 510K IS NOT APPLICABLE. WE DO HAVE SIMILAR MODEL EC38-I10CL-US AVAILABLE IN THE UNITED STATES WITH A 510K NUMBER K190805. THIS EVENT OCCURRED AT THE TIME OF DURING USE. NO VIDEO IMAGE-LOST PICTURE DURING PROCEDURE. PATIENT WAS SEDATED BUT THE DELAY DURING THE PROCEDURE REQUIRED THE SCOPE TO BE IN THE PATIENT LONGER WHILE WE FOUND AN ALTERNATIVE PROCESSOR TO USE TO SEE IF IT WAS THE SCOPE OR THE PROCESSOR. WE WERE ABLE TO GET THE PICTURE BACK AFTER GETTING A DIFFERENT PROCESSOR WHICH WE HAD TO RESEAT THE SCOPE SEVERAL TIMES BEFORE THE PICTURE CAME BACK. THE INITIAL PROCESSOR WE TRIED TO RESEAT THE SCOPE AND ALSO TURN IT ON AND OFF WITHOUT ANY SUCCESS. THE USER FACILITY RESPONDED TO OUR GOOD FAITH EFFORT(GFE) REQUEST VIA EMAIL ON 27-MAY-2021, WE CONFIRMED THAT THE PATIENT WAS ABLE TO GO HOME AFTER THE PROCEDURE THAT DAY. IN THIS CASE, THE IMAGE DISAPPEARED DURING THE ENDOSCOPY, AND THE IMAGE RETURNED TO NORMAL AFTER CHANGING THE PROCESSOR. THE FAILURE OF THE PROCESSOR, THE CONNECTION FAILURE BETWEEN THE SCOPE AND THE PROCESSOR IS ASSUMED THAT OCCURRED. DURING TIME TO BOOT THE PROCESSOR NORMALLY, ENDOSCOPIC PROCEDURES WERE SUSPENDED, BUT THERE WAS NO REPORT OF ADVERSE EVENT. AS RESULT OF CONDUCTING THE SECOND GOOD FAITH EFFORT(GFE) TO THE CUSTOMER VIA EMAIL ON 09-AUG-2021, WE FOUND THAT THE DEVICE WAITING TIME LEADING TO THE DELAY WAS 10-15 MINUTES AND ALSO CONFIRMED THAT THE PROCESSOR WAS WORKING FINE. EVALUATION SUMMARY: THE SCOPE WAS RETURNED; HOWEVER, THE PROCESSOR WAS NOT RETURNED BECAUSE OF NO FAILURE OCCURRED. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE FLUID DAMAGE FROM THE BENDING RUBBER, THE INSERTION FLEXIBLE TUBE (IFT), THE LIGHT GUIDE CABLE, AND THE REMOTE BUTTON. IN ADDITION, WE CONFIRMED THAT THE DISTAL BODY CHIP AND THE LG PRONG TOP ASSY LOOSENESS; HOWEVER, THESE ARE NOT RELATED TO THE ALLEGED COMPLAINT. IT IS RANDOM FAILURE. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 20-MAY-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 18MAR2019 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: UNIT TESTED ALL FUNCTION PASS. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: IMAGE BLACKOUT WHEN DEFLECTED, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, CONTROL BODY GRIP SCRATCHED, IMAGE DISTORTED, CONTROL BODY ROOT BRACE CUT, OPERATION CHANNEL- PRIMARY SHORT. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, SHIELD PIPE FOR CCD, SIGNAL WIRE FOR CCD, 0CB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY, O-RING (1.8X19.8), OPERATION CHANNEL, ROOT BRACE RUBBER LG BODY. THE ENDOSCOPE WAS APPROVED BY FINAL QC ON 28-JUN-2021 AND WAS DELIVERED TO THE CUSTOMER UNDER DELIVERY ORDER (B)(4). ON 21-JUN-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) FACILITY ON 30-MAY-2017 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 FOR 01-JUN-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245822 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333248209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other