BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUJINON

    MDR report key: 2877815 · Received December 13, 2012

    Report

    Report Number
    2431293-2012-00007
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 13, 2012
    Manufacturer
    FUJIFILM CORP.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) FIELD SERVICE ENGINEER VISITED THE USER FACILITY. ACCORDING TO THE PHYSICIAN THEY WERE INVESTIGATING ADVERSE EVENTS AND REQUESTED THAT THEIR LIGHT SOURCE BE INSPECTED. HE ASKED THAT THE AIR PRESSURE AND FLOW BE VERIFIED. THE PHYSICIAN REPORTED "POST-PROCEDURE DEVELOPMENT OF AIR EMBOLUS LEADING TO CEREBROVASCULAR COMPROMISE AND PERSISTENT NEUROLOGIC DYSFUNCTION AND/OR DEATH IN 2 ERCPS AND 1 EGD WITH ESOPHAGEAL BALLOON DILATION." THIS IS ONE OF THREE REPORTS, ALSO REFERENCE 241293-2012-00005 AND 241293-2012-00006. FMSU CHECKED THE PRESSURE AND AIR FLOW OF THE SUBJECT LIGHT SOURCE (X1-4400; SN: (B)(4)) AND SATISFACTORY RESULTS WERE OBTAINED. THE LIGHT SOURCE WAS ALLOWED TO RUN CONTINUOUSLY (5 HRS) AND HOURLY RESULTS WERE COLLECTED. THE LIGHT SOURCE WAS STABLE AND OPERATING WITHIN SPECIFICATION. A VISUAL INSPECTION OF THE LIGHT SOURCE NOTED SOME MINOR SCRATCHES ON THE TOP COVER. THE LIGHT SOURCE WAS SOLD TO THE CUSTOMER ON (B)(6) 2010, TO DATE, NO REPAIR HAVE BEEN PERFORMED ON THE SUBJECT UNIT AND APPEARS TO REMAIN EQUIPPED WITH OEM PARTS. THE USER FACILITY ALSO REPORTED A DUODENAL PERFORATION, HOWEVER THEY DID NOT RETURN THEIR ENDOSCOPE TO FMSU FOR INSPECTION. DUE TO THE AMOUNT OF TIME ELAPSED FROM WHEN THE PATIENT INCIDENT OCCURRED AND LIMITED INFORMATION AVAILABLE FROM THE CUSTOMER, THE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BASED ON FMSU'S INSPECTION RESULTS, NO EQUIPMENT MALFUNCTION COULD BE IDENTIFIED. THE LIGHT SOURCE HAD BEEN USED CLINICALLY SINCE THE INCIDENT ((B)(6) 2012) OCCURRED UNTIL THE LIGHT SOURCE WAS RETURNED TO FMSU ON (B)(6) 2012 FOR EVALUATION. IT WOULD APPEAR THAT THIS INCIDENT CAN EITHER BE ATTRIBUTED TO THE PATIENT'S CONDITION OR USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A CUSTOMER VISIT, FUJIFILM'S FIELD ENGINEER WAS INFORMED OF AN ADVERSE EVENT. ACCORDING TO HOSPITAL STAFF, THE "PATIENT UNDERWENT ERCP FOR COMMON BILE DUCT STONE EXTRACTION; POST-PROCEDURE, PT NOTED TO HAVE EXPERIENCED A DUODENAL PERFORATION AND CVA FROM PROBABLE AIR EMBOLISM." HE ALSO PROVIDED THAT THE "PATIENT'S CONDITION IS IMPROVING WITH REHABILITATION." THIS PATIENT IS NO LONGER AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON LIGHT SOURCE EOQ FUJIFILM CORP. XL-4400

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other