BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 13625849 · Received February 28, 2022

    Report

    Report Number
    9610877-2022-00287
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    February 8, 2022
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 MEDICAL DEVICE PROBLEM CODE: (B)(4). COMPONENT CODE: (B)(4). THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 08-FEB-2022. THE ENDOSCOPE WAS RETURNED AND INSPECTED BY PENTAX MEDICAL SERVICE ON (B)(6) 2022 UNDER WORK ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE OPERATION CHANNEL (PRIMARY): CUT AND THE FORWARD WATER JET TUBE WAS CLOGGED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: OPERATION CHANNEL (PRIMARY), WATER JET TUBE, BENDING RUBBER, ANGLE WIRE, ADJUSTING COLLAR. MODEL EC38-I10L, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. ON (B)(6) 2022, 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)(6) FACILITY ON 04-MAR-2015 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 (B)(6) 2015. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MDR 2518897-2022-00194 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4) FOR THE (B)(6) 2022 AWARE DATE. MDR 2518897-2022-00195 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4) FOR THE (B)(6) 2021 AWARE DATE.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE WATER JET TUBE WAS CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY. IN ADDITION, WE CONFIRMED THAT THE OPERATION CHANNEL CUT; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR. CORRECTION INFORMATION: G6: FOLLOW UP #1 H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION: H4: DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G4: PREMARKET IDENTIFICATION PMA/510(K). G6: FOLLOW UP #3. H2: TYPE OF FOLLOW UP.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A: PATIENT INFORMATION. CORRECTION INFORMATION: H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS EVENT IS BELIEVED TO HAVE BEEN CAUSED BY INCORRECT WATER JET DUE TO CLOGGING OF THE PIPELINE, AND IS NOT DUE TO DESIGN/MANUFACTURING. IF THE ABNORMALITY OF THE SECONDARY WATER SUPPLY FUNCTION AFFECTS THE PROCEDURE, IT CAN BE DETECTED BY THE PRE-USE INSPECTION ACCORDING TO THE IFU. IF IT IS AT A LEVEL THAT CANNOT BE DETECTED IN THE PRE-USE INSPECTION, IT IS CONSIDERED NOT TO AFFECT THE PROCEDURE. IN ADDITION, THE AUXILIARY WATER SUPPLY FUNCTION IS USED TO WASH THE PATIENT'S BLEEDING POINT, ETC., AND IT IS UNLIKELY THAT THIS FUNCTION WILL DAMAGE THE PATIENT'S MUCOUS MEMBRANES. CORRECTION INFORMATION: G6: FOLLOW UP #4 H2: TYPE OF FOLLOW UP H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. ON (B)(6) 2021, THE CUSTOMER INITIALLY REPORTED THAT THE DISTAL END OF THE ENDOSCOPE WAS CRUSHED AND CAUSING MUCOSAL TRAUMA TO THE PATIENT DURING PROCEDURE INVOLVING PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4). IT REPORTEDLY HAPPENED IN MULTIPLE INSTANCES WITH DIFFERENT PHYSICIANS, PATIENTS, AND PROCEDURE ROOMS. THE USER FACILITY RECEIVED THE ENDOSCOPE BACK FROM PENTAX MEDICAL SERVICE REPAIR AND WHEN USING THE DEVICE ON (B)(6) 2022, THE CUSTOMER REPORTED IT AGAIN CAUSED MUCOSAL TRAUMA WITH BLEEDING TO THE PATIENT DURING THE PROCEDURE. THE USER FACILITY HAS PULLED IT OUT OF USE AND RETURNED THE ENDOSCOPE FOR FURTHER EVALUATION. THE USER FACILITY ALSO MENTIONED RESISTANCE AUXILIARY BIOPSY CHANNEL, AND AFTER DISCUSSING WITH THEIR PENTAX SALES REP, REQUESTED THE DISTAL ENDS AND TUBING BE REPLACED. 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
    942965 PENTAX VIDEO COLONO SCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other