BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 13619364 · Received February 28, 2022

    Report

    Report Number
    9610877-2022-00448
    Event Type
    Injury
    Date Received
    February 28, 2022
    Report Date
    June 20, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131855
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. (B)(4). THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 17-DEC-2021. THE ENDOSCOPE WAS RETURNED TO PENTAX MEDICAL ON 17-DEC-2021. UNDER WORK ORDER (B)(4) AND THE TECHNICIAN THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER WORK ORDER (B)(4) AND THE SERVICE TECHNICIAN WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT BUT DID DOCUMENT THE FOLLOWING INSPECTION FINDINGS: REMOTE CONTROL BUTTON(1): CRACKED, BENDING RUBBER GLUING: DISCOLORED, NOZZLE GLUING: DIRTY, UP PULLEY WIRE: WORN OUT, LEFT PULLEY WIRE: WORN OUT. THE ENDOSCOPE WAS REPAIRED AND APPROVED BY FINAL QC ON 21-JAN-2022 AND WAS DELIVERED TO THE CUSTOMER. MODEL EC38-I10L, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. ON 09-FEB-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)(4) 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 05-MAR-2015. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MDR 9610877-2022-00287 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC38-I10L, SERIAL NUMBER (B)(4) FOR THE FEBRUARY 8, 2022 AWARE DATE.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B4: DATE OF THIS REPORT. G4:PREMARKET IDENTIFICATION PMA/510(K). G6: FOLLOW UP #2. H2: IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION: A SUPPLEMENTAL REPORT 1 SUBMITTED ON 05-SEP-2022 WAS FOUND TO BE INCORRECT. FOUND ON 17-JUN-2023 THAT IT IS NOT A DUPLICATE OF MDR (9610877-2022-51023). WE SUBMIT A SUPPLEMENTAL REPORT 2. EVALUATION SUMMARY: THE USER FACILITY DID DOCUMENT THAT THE FOLLOW PRE-PROCEDURAL CHECKS AND IFUS FOR DEVICES AND ACCESSORIES. THE DEVICE WAS RETURNED AND EVALUATED. IT WAS CONFIRMED THAT THE WATER JET TUBE WAS CLOGGED. BASED ON THE INVESTIGATION RESULTS, IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE CLOGGED WATER JET TUBE WAS INSUFFICIENT REPROCESSING AT THE USER FACILITY. IN ADDITION, THE PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 0

    DURING PENTAX INTERNAL REVIEW, THE SAME EVENT WAS FILED UNDER MDR (9610877-2022-51023) WHICH WAS SUBMITTED. THEREFORE, MDR (9610877-2022-00448) FILED ON FEBRUARY 28, 2022 IS CONSIDERED A DUPLICATE REPORT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905777 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other