BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM ENDOSCOPE EC-760R-V/L

    MDR report key: 8946727 · Received August 29, 2019

    Report

    Report Number
    1000513161-2019-00007
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 13, 2019
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REF: INTERNAL COMPLAINT NUMBER (B)(4). ON 02 SEP 2019 FMSU BECAME AWARE OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 05 AUG 2019 FUJIFILM MEDICAL SYSTEMS U.S.A INC. (FMSU) WAS INFORMED THAT A POLYPECTOMY PROCEDURE WITH A FUJIFILM ENDOSCOPE RESULTED IN A MUCOSAL ABRASION/TEAR. THE IN-ROOM TECHNICIAN INDICATED THAT THE PHYSICIAN WAS USING THE NUMBER 3 SETTING ON THE FAM ALONG WITH A THIRD PARTY STIFFENING WIRE (STIFFEST MODEL) WHILE THE TECHNICIAN WAS APPLYING PRESSURE. THE PHYSICIAN SAID THAT THE PATIENT WAS BEING TREATED FOR POLYPS AND THERE WAS SLIGHT TRAUMA TO THE COLON IN WHICH THE PHYSICIAN BELIEVED WAS ENDOSCOPIC SCOPE TRAUMA; A TEAR THAT WAS APPROXIMATELY 1.5 CM LONG. THE PHYSICIAN AND HIS MEDICAL STAFF BELIEVE IT WAS CAUSED BY THE RIDGES OF THE TIP OF THE SCOPE. IT WAS CONFIRMED THAT THERE WERE NO SERIOUS INJURIES AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME SCOPE; THE TEAR WAS TREATED WITH CLIPS. AFTERWARDS, THE PATIENT WAS SENT FOR A CT SCAN AS A SAFETY PRECAUTION; THE RESULTS WERE NORMAL. THE PHYSICIAN CONFIRMED THAT THE PATIENT IS FINE, THE PATIENT WAS NOT HOSPITALIZED AND DID NOT NEED ADDITIONAL MEDICAL ATTENTION. THE PHYSICIAN WAS UNSURE HOW MANY OTHER PATIENTS RECEIVED TREATMENT WITH THE SAME SCOPE, HOWEVER, THERE WERE NO SIMILAR REPORTS OR PATIENT INJURY RELATED TO THIS SCOPE. THE PHYSICIAN CONFIRMED THAT THE SCOPE WAS TAKEN OUT OF USE AND WAS SAVED FOR THE SALES REPRESENTATIVE TO BE SENT FOR EVALUATION; SCOPE WAS SENT TO FMSU FOR INSPECTION. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2019 FUJIFILM MEDICAL SYSTEMS U.S.A INC. (FMSU) WAS INFORMED THAT A POLYPECTOMY PROCEDURE WITH A FUJIFILM ENDOSCOPE RESULTED IN A MUCOSAL ABRASION/TEAR. THE IN-ROOM TECHNICIAN INDICATED THAT THE PHYSICIAN WAS USING THE NUMBER 3 SETTING ON THE FAM ALONG WITH A THIRD PARTY STIFFENING WIRE (STIFFEST MODEL) WHILE THE TECHNICIAN WAS APPLYING PRESSURE. THE PHYSICIAN SAID THAT THE PATIENT WAS BEING TREATED FOR POLYPS AND THERE WAS SLIGHT TRAUMA TO THE COLON IN WHICH THE PHYSICIAN BELIEVED WAS ENDOSCOPIC SCOPE TRAUMA; A TEAR THAT WAS APPROXIMATELY 1.5 CM LONG. THE PHYSICIAN AND HIS MEDICAL STAFF BELIEVE IT WAS CAUSED BY THE RIDGES OF THE TIP OF THE SCOPE. IT WAS CONFIRMED THAT THERE WERE NO SERIOUS INJURIES AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME SCOPE; THE TEAR WAS TREATED WITH CLIPS. AFTERWARDS, THE PATIENT WAS SENT FOR A CT SCAN AS A SAFETY PRECAUTION; THE RESULTS WERE NORMAL. THE PHYSICIAN CONFIRMED THAT THE PATIENT IS FINE, THE PATIENT WAS NOT HOSPITALIZED AND DID NOT NEED ADDITIONAL MEDICAL ATTENTION. THE PHYSICIAN WAS UNSURE HOW MANY OTHER PATIENTS RECEIVED TREATMENT WITH THE SAME SCOPE, HOWEVER, THERE WERE NO SIMILAR REPORTS OR PATIENT INJURY RELATED TO THIS SCOPE. THE PHYSICIAN CONFIRMED THAT THE SCOPE WAS TAKEN OUT OF USE AND WAS SAVED FOR THE SALES REPRESENTATIVE TO BE SENT FOR EVALUATION; SCOPE WAS SENT TO FMSU FOR INSPECTION. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741338 FUJIFILM ENDOSCOPE EC-760R-V/L FUJIFILM ENDOSCOPE FDS FUJIFILM CORPORATION EC-760R-V/L N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention