BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 10731127 · Received October 23, 2020

    Report

    Report Number
    9610877-2020-00174
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 24, 2020
    Report Date
    April 20, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #01. H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. TYPE OF INVESTIGATION: 4114 DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 4248 USAGE PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 61 UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. AS A RESULT OF THE INTERNAL INVESTIGATION PERFORMED BY THE MANUFACTURER UNDER CAPA NUMBER CAPA-PAI-21-030117, IT WAS DETERMINED THE DISTAL END CAP(DEC) BEING DISLODGED WAS NOT RELATED TO DESIGN OR MANUFACTURING. IT WAS DETERMINED THAT IMPROVED TRAINING AND CLARIFICATION OF LABELING (IFUS) WOULD BE HELPFUL IN ENSURING PROPER ATTACHMENT AND CONTINUED SAFE USE OF THE DEVICE. REFER TO RESOLUTION SECTION FOR ADDITIONAL DETAILS. AS A RESULT OF THE DEC INVESTIGATION AND ASSOCIATED CAPA, PENTAX HAS UPDATED THE LABELING (BOTH THE DISTAL END CAP IFU AND THE DUODENOSCOPE IFU) FOR ED34-I10T2. THE INSTRUCTIONS WERE UPDATED TO INCLUDE ADDITIONAL WORDING AND ILLUSTRATIONS TO HELP ENSURE A MORE SECURE ATTACHMENT OF THE DISTAL END CAP. IN ADDITION, THE WARNING SECTION OF THE IFUS HAVE BEEN UPDATED TO NOTIFY USERS OF THE ASSOCIATED RISKS WITH THE DISTAL END CAP (OEA63) UNEXPECTEDLY BECOMING DETACHED DURING A PROCEDURE. THE UPDATE ALSO NOTIFIES USERS OF WHAT IMMEDIATE ACTIONS SHOULD BE TAKEN IN CASE THE EVENT OCCURS. THESE CHANGES WERE CLEARED IN 510(K) K210710 AND DISTRIBUTED TO THE INSTALLED BASE VIA A 21 CFR806.10 FIELD CORRECTIVE ACTION (2021-004-C). IN ADDITION, A QUICK REFERENCE GUIDE UTILIZING EXISTING LABELING WAS CREATED, LAMINATED AND ATTACHED TO VIDEO PROCESSOR CARTS AT ALL US CUSTOMERS OF THE ED34-I10T2. TRAINING TO THE QUICK REFERENCE GUIDE WAS COMPLETED AT ALL SITES, AND AN INSTRUCTIONAL VIDEO WAS PRODUCED AND HAS BEEN DISTRIBUTED TO ALL SITES. THE IN-SERVICE VIDEO PROVIDES INSTRUCTIONS ON PROPER ATTACHMENT OF THE DISPOSABLE END CAP TO ED34-I10T2 WAS CREATED AND DISTRIBUTED VIA SHOWPAD AND PENTAX YOUTUBE. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST DISTAL END CAP THAT REPORTEDLY FELL INTO THE PATIENT'S MOUTH WILL BE REPORTED UNDER MDR 9610877-2020-00174. THE SECOND DISTAL END CAP THAT REPORTEDLY BROKE APART WHILE TRYING TO BE INSTALLED WILL BE REPORTED UNDER MDR 9610877-2020-00175.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE DISPOSABLE DISTAL END CAP (DEC) "CAME OFF OF THE ED34-I10T2 WHILE IN THE PATIENTS MOUTH AS PROCEDURE WAS STARTING. THEY RETRIEVED THE CAP AND TRIED INSTALLING A NEW ONE BUT THAT ONE BROKE APART WHEN TRYING TO INSTALL. THEY USED A THIRD CAP AND PROCEDURE WAS COMPLETED NORMALLY. THE PROCEDURE REQUIRED MEDICAL INTERVENTION TO REMOVE THE DISLODGED DISTAL END CAP FROM THE PATIENT". SINCE THE SECOND DEC BROKE DURING INSTALLATION DURING THE PROCEDURE, WE ARE ALSO REPORTING IT IN AN OVER ABUNDANCE OF CAUTION. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. A PENTAX MEDICAL TERRITORY MANAGER VISITED THE SITE AND GATHERED PRODUCT INFORMATION FOR THE DISTAL END CAPS AND ENDOSCOPE. HE ALSO RETRAINED THE STAFF MEMBER ON APPLICATION, TESTING AND REMOVAL OF DISTAL END CAPS. THE PROCEDURE INVOLVED PENTAX MEDICAL STERILE DISTAL END CAP ACCESSORY, MODEL OE-A63, LOT NUMBER 0011089. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). PATIENT INFORMATION WAS NOT PROVIDED BY THE USER FACILITY. ON 21-AUG-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL OE-A63, LOT NUMBER 0011089 WAS PERFORMED UNDER (B)(4), THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 01-AUG-2019 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 09-AUG-2019. INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190911 PENTAX STERILE DISTAL END CAP FDT OE-A63 0011089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention