BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUJINON

    MDR report key: 3142888 · Received May 30, 2013

    Report

    Report Number
    2431293-2013-00004
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 2, 2013
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    PMA / PMN Number
    K090116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON LEARNING THAT THERE HAD BEEN A POTENTIAL PATIENT DEATH AT (B)(6), FMSU CONTACTED THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THE INCIDENT, THE EQUIPMENT OR ACCESSORIES USED, PATIENT INFORMATION, ACTUAL DATE OF DEATH AND ANY OTHER PERTINENT INFORMATION THAT COULD ASSIST IN INVESTIGATING THE ROOT CAUSE OF THE INCIDENT. FMSU LEARNED FROM (B)(6) THAT THE PATIENT HAD UNDERGONE AN ERCP PROCEDURE AND STATED THAT THE PATIENT DIED FROM AN AIR EMBOLISM. NO ALLEGATION OF PRODUCT MALFUNCTION. FMSU ALSO REQUESTED THAT THE SUBJECT DEVICE AND EQUIPMENT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. (B)(6) STATED THEY WOULD NOT RELEASE THE DEVICE AND EQUIPMENT TO FMSU UNTIL THEY COMPLETED THEIR INVESTIGATION OF THE EQUIPMENT PER HOSPITAL POLICY. MULTIPLE REQUESTS BY PHONE ON ((B)(6) 2013) HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE, (B)(6) HAS NOT RETURNED THE EQUIPMENT TO FMSU NOR HAVE THEY PROVIDED ANY OTHER INFORMATION RELATED TO THE PATIENT PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, FUJIFILM MEDICAL SYSTEMS U.S.A, INC. (FMSU) WAS CONTACTED BY (B)(6) REQUESTING A LOANER SCOPE. WE WERE INFORMED THAT VMMC WAS REQUESTING A LOANER SCOPE AS THE CURRENT EQUIPMENT WAS BEING INVESTIGATED IN CONNECTION WITH A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238476 FUJINON DOUBLE BALLOON ENDOSCOPE FDF FUJIFILM CORPORATION EC-450BI5

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death VP-402, SN# (B)(4)| OVERTUBE AND BALLONS:| PB-20, SN# (B)(4)| XL- 4400, SN# (B)(4)| OLYMPUS UCR (CO2 INSUFFLATOR):