BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17257361 · Received July 5, 2023

    Report

    Report Number
    9610877-2023-00175
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    February 28, 2023
    Report Date
    July 4, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333247455
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE WAS REPROCESSED AND SAMPLED A SECOND TIME WITH RESULTS OF NO GROWTH. PENTAX MEDICAL CONDUCTED AN INVESTIGATION TO DETERMINE IF A ROOT CAUSE CAN BE DETERMINED. THE INVESTIGATION REVEALED NO PRODUCT PROBLEM. ALTHOUGH NO BREACH IN STERILE SAMPLING WAS IDENTIFIED, BASED ON REPROCESSING DOCUMENTATION OF THE INITIAL AND SECOND SAMPLING TIMING IT IS IMPOSSIBLE TO DETERMINE IF A POTENTIAL DELAY IN REPROCESSING OCCURRED. THIS POTENTIAL DELAY IN REPROCESSING WOULD BE NOTED AS USER ERROR IN THE REPROCESSING PROCESS. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 22-JUN-2021 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 ON 22-JUN-2021.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPROCESSING FAILURE BY THE USER FACILITY DURING A (B)(4) STUDY. THERE IS NO KNOWN ADVERSE EVENT. THE DEC DUODENOSCOPE SAMPLE COLLECTED ON (B)(6) 2023 TESTED POSITIVE FOR A LOW/MODERATE RISK MICRO-ORGANISM WITH >100CFU WHEN THE MICROBIOLOGIST READ THE FINAL LAB ISSUE REPORT ON (B)(6) 2023. DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER N111032 INITIAL SAMPLE RESULTS: 117 CFU; 115 CFU BACILLUS ALTITUDINIS / AEROPHILUS; 2 CFU STAPHYLOCOCCUS EPIDERMIDIS. PER THE (B)(4) STUDY PROTOCOL, ENDOSCOPES WITH LOW/MODERATE CONCERN MICROORGANISMS > 100CFU CANNOT BE RELEASED AND MUST BE REPROCESSED AND SAMPLED AGAIN. THE DUODENOSCOPE WAS REPROCESSED ON (B)(6) 2023 AND SAMPLED AGAIN ON (B)(6) 2023. RESULTS OF THIS SAMPLE WERE READ BY THE MICROBIOLOGIST ON (B)(6) 2023. THE SECOND SAMPLE REVEALED NO GROWTH. THE MICROBIOLOGIST RELEASED THE DUODENOSCOPE FOR REPROCESSING AND CLINICAL USE AS THERE WAS NOTHING TO INDICATE A BIOFILM OR MALFUNCTION. DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6) SECOND SAMPLE RESULTS: NO GROWTH / 0CFU. NO ACTIONS NEEDED, ENDOSCOPE CAN BE RELEASED FROM QUARANTINE. PENTAX MEDICAL CLINICAL AFFAIRS ASSOCIATE DOES NOT THINK THE INITIAL FAILED SAMPLING RESULT WAS RELATED TO THE REPROCESSING, AS THE BACTERIA FROM THE (B)(6) 2023 SAMPLING WERE MOSTLY FROM ENVIRONMENTAL/SKIN ORIGIN. BASED ON THE CLINICAL AFFAIRS INVESTIGATION, THEY CONFIRMED THE DUODENOSCOPE WAS PROPERLY STORED IN A CLEAN ENDOSCOPE ROOM CABINET BEFORE SAMPLING AND THEY COULD NOT DETERMINE A POSSIBLE BREACH IN STERILE SAMPLING. HOWEVER DUE TO THE LENGTH OF TIME BETWEEN THE FIRST SAMPLE AND THE REPORT FROM THE SECOND SAMPLE, IT WAS IMPOSSIBLE TO DETERMINE WHERE THE DELAY IN REPROCESSING OCCURRED. IT WAS IMPOSSIBLE TO DETERMINE IF THERE WAS A DELAY IN REPROCESSING. THIS SITE PERFORMS MANUAL CLEANING AND USES THE AUTOMATED ENDOSCOPE REPROCESSORS(AERS) FOR HIGH-LEVEL DISINFECTANTS (HLDS)ONLY. 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
    1775176 PENTAX VIDEO DUODENO SCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333247455

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown