BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 19218498 · Received April 30, 2024

    Report

    Report Number
    9610877-2024-00041
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    February 19, 2024
    Report Date
    June 24, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K200678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 1735 BACTERIAL INFECTION HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION MEDICAL DEVICE PROBLEM CODE: 1120 CONTAMINATION COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE TYPE OF INVESTIGATION:10 TESTING OF ACTUAL/SUSPECTED DEVICE INVESTIGATION FINDINGS:3233 RESULTS PENDING COMPLETION OF INVESTIGATION CONCLUSIONS:11 CONCLUSION NOT YET AVAILABLE ADDITIONAL INFORMATION: SEVERAL PATIENTS HAVE BEEN INFECTED WITH PSEUDOMONAS AERUGINNOSA (PYO). BUT THE NUMBER OF PATIENTS IS UNKNOWN. THE SUSCEPTIBILITY TEST REVEALED DIFFERENT STRAINS BUT THAT THEIR GENETIC ANALYSIS COULD NOT BE CARRIED OUT DUE TO THE NON-STORAGE OF THE SAMPLES. CULTURE RESULTS PERFORMED BY THE FACILITY ON SPECIMENS TAKEN FROM THE ENDOSCOPE DETECTED 1 CFU OF BACILLUS GRAM-POSITIVE BACTERIA, BUT NO PSEUDOMONAS AERUGINOSA. THE REPROCESSING WAS SUCCESSFUL ON 2024-02-21 (TWO DAYS AFTER THE INCIDENT). THE MICROBIOLOGICAL SAMPLING ON 2024-02-21 WAS PASSED, NO PATHOGENS HAVE BEEN DETECTED. BASED ON YOUR INVESTIGATIONS, YOUR CURRENT ANALYSIS DOES NOT IDENTIFY WHETHER THE SOURCE IS THE ENDOSCOPE OR THE ENVIRONMENTAL SOURCE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 1735 BACTERIAL INFECTION HEALTH EFFECT IMPACT CODE: 4648 INSUFFICIENT INFORMATION MEDICAL DEVICE PROBLEM CODE: 1120 CONTAMINATION COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE TYPE OF INVESTIGATION:4110 TREND ANALYSIS, 3331 ANALYSIS OF PRODUCTION RECORDS, 10 TESTING OF ACTUAL/SUSPECTED DEVICE INVESTIGATION FINDINGS:4229 DEVICE INCORRECTLY CLEANED DURING REPROCESSING INVESTIGATION CONCLUSIONS:19 CAUSE TRACED TO USER CORRECTION INFORMATION B4: DATE OF THIS REPORT H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT . EVALUATION SUMMARY THE DEVICE OF CONCERN WAS SUBMITTED TO SERVICE AT PENTAX FRANCE ON 2019-10-02 FOR THE LAST TIME AND THE DEVICE WAS FOUND IN POOR CONDITION (I.E. NON-OPERATIONAL CONDITION) AT PENTAX SERVICE ON 2024-03-04. BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE IS THE USER DETERMINED THAT THE REPROCESSING WAS INAPPROPRIATE. THE DEVICE HAS BEEN SUCCESSFULLY REPROCESSED AND REPAIRED. WE CONCLUDE THE EB15-J10 DID NOT CONTRIBUTE TO THE BACTERIAL CONTAMINATION OF ANY PATIENT EVEN THOUGH THE DEVICE WAS NOT IN OPERATIONAL CONDITION. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 21-JUN-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 ON 21-JUN-2017. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    ON 04-APR-2024, PENTAX MEDICAL EMEA RECEIVED A NOTIFICATION SENT BY THE NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS(ANSM) REGARDING A PATIENT CONTAMINATION WHICH OCCURRED ON 19-FEB-2024. AN UNSPECIFIED RESPIRATORY INFECTION WAS NOTED IMPLICATING MICROORGANISM: PSEUDOMONAS AERUGINOSA [NMR] CONTAMINATION BY THE BRONCHOSCOPE OR THE ENVIRONMENT. THE USER SUBMITTED THE BRONCHOSCOPE FOR ANALYSIS BY PENTAX MEDICAL WITH THE SUSPICION OF CONTAMINATION. 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
    155805 PENTAX BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB15-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other