BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 19681405 · Received July 5, 2024

    Report

    Report Number
    2518897-2024-00032
    Event Type
    Injury
    Date Received
    July 5, 2024
    Report Date
    July 5, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. HEALTH EFFECT CLINICAL CODE: 1735 BACTERIAL INFECTION. HEALTH EFFECT IMPACT CODE: 4614 SERIOUS INJURY/ILLNESS/IMPAIRMENT. MEDICAL DEVICE PROBLEM CODE: 2303 MICROBIAL CONTAMINATION OF DEVICE, 3190 INSUFFICIENT INFORMATION. COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. SUMMARY: ALTHOUGH THEY DID NOT STATE THAT THE INFECTION IDENTIFIED IN CASE 1 WAS CLEARLY RELATED TO THE ENDOSCOPY, THEY DID STATE THAT THE ISOLATED MICROORGANISM HAD A GENETIC LINK. HOWEVER, IT CANNOT BE RULED OUT THAT THE PATIENT HAD ALREADY TESTED POSITIVE FOR THE MICROORGANISM, WHICH MAY HAVE CONTAMINATED THE ENDOSCOPE. PENTAX MEDICAL WAS ABLE TO MEET WITH THE AUTHORS OF THE PAPER AND DURING THE INTERVIEWS,AND LEARNED THAT THERE WERE PROBLEMS AT THE FACILITY WHICH ALLOWED A MICROFILM TO BUILD UP AND THE ENDOSCOPE COULD NOT BE EFFECTIVELY CLEANED. ALTHOUGH MULTIPLE INFECTIONS RELATED TO DUODENOSCOPES MAY HAVE OCCURRED OUTSIDE OF CCSE 1, NO SERIOUS INJURIES, EQUIPMENT FAILURES, CROSS-CONTAMINATION, OR DEATHS RELATED TO DUODENOSCOPES USED IN THE AREA OF THIS STUDY HAVE BEEN REPORTED, AND PENTAX MEDICAL WAS UNABLE TO CONFIRM SPECIFIC USER FACILITIES, EVENT DATES, SAMPLING DATES, OR PATIENT CASES THAT MAY HAVE BEEN EXPOSED TO CROSS-CONTAMINANTS. WITHOUT SPECIFIC PRODUCT INFORMATION, WE ARE UNABLE TO INVESTIGATE FURTHER. SIMILARLY, BECAUSE PRODUCTS ARE NOT RETURNED FOR EVALUATION, WE ARE UNABLE TO INVESTIGATE OR CONFIRM THE FAILURE MODE AND THEREFORE THE ROOT CAUSE CANNOT BE IDENTIFIED. ADDITIONAL DETAILS CAN BE FOUND WITHIN THE ARTICLE: JOURNAL OF HOSPITAL INFECTION 147 (2024) 56-62; "A SEARCH STRATEGY FOR DETECTING DUODENOSCOPEASSOCIATED INFECTIONS: A RETROSPECTIVE OBSERVATIONAL STUDY". IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. IMPORTER MDR 2518897-2024-00031, ED34-I10T2, UNKNOWN SERIAL NUMBER. ED34-I10T, UNKNOWN SERIAL NUMBER.

    Description of Event or Problem · 0

    ON JUNE 18, 2024, A SCIENTIFIC ARTICLE WAS OBTAINED BY PENTAX MEDICAL REPORTING ON AN INSPECTION STRATEGY FOR DETECTING DUODENOSCOPY-ASSOCIATED INFECTIONS (DAI) DUE TO DUODENOSCOPY CONTAMINATION. ACCORDING TO THE ARTICLE, THE AUTHORS STATE THAT THE SPREAD OF INFECTION BY NONMULTIDRUG-RESISTANT AS WELL AS MULTIDRUG-RESISTANT ORGANISMS MAY OCCUR FOR DAI CAUSED BY CONTAMINATED DUODENOSCOPES. A TOTAL OF 1803 PATIENTS WERE IDENTIFIED AS POSSIBLY HAVING BEEN EXPOSED TO CONTAMINATED DUODENOSCOPES. SIXTY-EIGHT(68) OF THESE PATIENTS (3.8%) DEVELOPED INFECTIONS WITHIN ONE YEAR AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP), WHICH WERE IDENTIFIED BY MICROORGANISMS THAT MATCHED THE DUODENOSCOPE CULTURES USED FOR TREATMENT AND THE PATIENT'S INFECTION AT THE SPECIES LEVEL. THE INFECTIONS IN THE 68 PATIENTS WERE IDENTIFIED AS SPECIES-LEVEL IDENTICAL BETWEEN THE ISOLATES OBTAINED FROM BLOOD CULTURES AND THE ISOLATES OBTAINED FROM DUODENOSCOPES, AND IT HAS NOT BEEN DETERMINED THAT THE DUODENOSCOPES USED IN THE EXAMINATIONS CAUSED CROSS-INFECTION. HOWEVER, IT ALSO DOES NOT CLEARLY STATE THAT THE DUODENOSCOPE USED IN THE INSPECTION WAS NOT THE CAUSE OF THE INFECTION. NO NUMBER OF INFECTED PATIENTS, EQUIPMENT FAILURES, SERIOUS ILLNESSES, OR DEATHS WERE REPORTED FOR THE DUODENOSCOPES USED IN THIS STUDY FOR THE RESPECTIVE ENDOSCOPES. THEREFORE, PENTAX MEDICAL WAS UNABLE TO IDENTIFY THE USER FACILITY, THE DATE OF THE EVENT, THE DATE OF SAMPLING, OR THE PATIENT CASES THAT MAY HAVE BEEN EXPOSED TO CROSS-CONTAMINANTS. PENTAX MEDICAL IDENTIFIED TWO CASE REPORTS THAT ARE BEING REPORTED WITH CAUTION TO ENSURE COMPLIANCE WITH THE REPORTING REQUIREMENTS OF THE AUTHORITIES. CASE 1 WILL BE ADDRESSED BY IMPORTER MDR REPORT 2518897-2024-00032. ALTHOUGH A CAUSAL RELATIONSHIP BETWEEN THE DUODENOSCOPE CONTAMINATION AND PATIENT INFECTION AND DEATH HAS NOT BEEN EXPLICITLY STATED, THERE IS NO BASIS FOR DEFINITIVELY DENYING IT, AND THEREFORE, THIS EVENT IS FDA REPORTABLE. 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
    901902 PENTAX VIDEO DUODENO SCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization