BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM VIDEO COLONOSCOPE

    MDR report key: 10307493 · Received July 22, 2020

    Report

    Report Number
    3001722928-2020-00011
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 22, 2020
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    UDI-DI
    14547410337393
    PMA / PMN Number
    K160196
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO FUJIFILM MEDICAL SYSTEMS USA INC. (FMSU) FOR INSPECTION. THE INSPECTION DID NOT REVEAL ANY SHARP EDGES OR ANY OTHER FAULTS. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON JULY 01, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE FOR DIAGNOSTIC PURPOSES A TEAR OCCURRED IN THE PATIENT'S COLON; FMSU NOTIFIED FUJIFILM CORPORATION OF THE EVENT ON JULY 07, 2020. THIS OCCURRED DURING THE FINAL STAGES OF THE PROCEDURE, THE DOCTOR RETROFLEXED THE SCOPE IN THE COLON WHICH LED TO THE TEAR. THE DOCTOR APPLIED A MEDICAL CLIP TO THE TEAR, WHICH WILL BE EXPELLED WITH THE PATIENT'S BOWEL MOVEMENT WITHIN THE NEXT MONTH ONCE THE TEAR HAS HEALED. THE PATIENT WAS RELEASED FROM THE ENDOSCOPY CENTER AFTER THE PROCEDURE WAS COMPLETED. THE SCOPE WAS TAKEN OUT OF USE AFTER THE PROCEDURE WAS COMPLETED. THE DOCTOR BELIEVED THAT THERE WAS A SHARP EDGE AT THE DISTAL END WHICH LED TO THE TEAR IN THE PATIENT. HOWEVER AFTER FURTHER INSPECTION OF THE COLONOSCOPY SCOPE, WHICH WAS INSPECTED BY THE LEAD ENDOSCOPY TECHNICIAN, THERE WAS NO SIGN OF ANY SHARP EDGES. THE TECHNICIAN DID NOT BELIEVE THAT THIS WAS A USER ERROR; HOWEVER THERE WAS ALSO NO PROOF TO SUGGEST OTHERWISE. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775168 FUJIFILM VIDEO COLONOSCOPE VIDEO ENDOSCOPE FDF FUJIFILM CORPORATION EC-600WL V2 N/A 14547410337393

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention