BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJINON

    MDR report key: 6661091 · Received June 22, 2017

    Report

    Report Number
    2431293-2017-00065
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 23, 2017
    Report Date
    January 14, 2020
    Manufacturer
    FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE
    Product Code
    FDA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06 JAN 2020 FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) WAS NOTIFIED BY THE FDA THAT THE FOLLOW UP WAS SUBMITTED WITH INCORRECT SEQUENCE NUMBERS (ORIGINALLY FOLLOW-UP INFORMATION WAS SUBMITTED UNDER 3001722928-2018-00003- 1). ADDITIONAL UPDATES: A2: DATE OF BIRTH. D3: MANUFACTURER HAS BEEN RE-REGISTERED UNDER FUJIFILM CORPORATION. D4: INDICATED N/A FOR FIELDS THAT ARE NOT APPLICABLE, UDI- UNKNOWN. E1-E3: INITIAL REPORTER WAS NOT PROVIDED. G1, G2: UPDATING TO INCLUDE THE CURRENT CONTACT FOR THE MANUFACTURER. G5: NOT AVAILABLE BECAUSE DEVICE IS NOT MARKETED AND SOLD IN THE U.S., HOWEVER SIMILAR TO MODEL EN-580T IS U.S. H6- CONCLUSION CODE 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION) IS NO LONGER AVAILABLE IN THE FDAS CODE DATABASE, THEREFORE CONCLUSION CODE 67 IS BEING USED. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H10: INFORMATION AS SUBMITTED IN THE FOLLOW-UP REPORT 3001722928-2018-00003- 1: THIS SUPPLEMENT REPORT PERTAINS TO INITIAL MDR 2431293-2017-00065: SINCE THE INITIAL REPORT WAS FILED, FUJIFILM HAS OBTAINED INFORMATION ON THE OUTCOME TO THE PATIENT. IN ADDITION, INDEPENDENT MEDICAL ASSESSMENTS WERE OBTAINED TO HELP IN DETERMINING WHAT MAY HAVE BEEN THE CAUSE OF THE PERFORATION. FUJIFILM HEREBY PROVIDES THE FOLLOWING ADDITIONAL INFORMATION. PATIENT OUTCOME: THE RESULTING PATIENT BOWEL PERFORATION WAS FOUND TO BE INCONSEQUENTIAL, IN THAT SURGERY WAS NOT NECESSARY. ON JUNE 6, 2017, CONFIRMATION WAS OBTAINED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD RECOVERED WITH NO NEED FOR FURTHER INTERVENTION. INDEPENDENT MEDICAL DOCTOR OPINIONS: CLINICAL IMAGES OF THE PERFORATION CONCERNED WERE PRESENTED TO FIVE SPECIALIZED PHYSICIANS FOR THEIR MEDICAL OPINIONS. THE JUDGEMENT OF FOUR OUT OF THE FIVE PHYSICIANS WAS THAT "ROTATING THE RETROFLEXED SCOPE DURING THE PROCEDURE WAS NOT THE CAUSE OF THE PERFORATION. THE PERFORATION PROBABLY DID NOT OCCUR DURING THE ROTATING OF THE RETROFLEXED SCOPE BUT DUE TO EXCESS FORCE DURING INSERTION OF THE SCOPE." THE FIFTH PHYSICIAN JUDGED THAT ROTATING THE RETROFLEXED SCOPE DURING THE PROCEDURE MIGHT HAVE OR MIGHT NOT HAVE CAUSED THE PERFORATION (INCONCLUSIVE). MOST LIKELY CAUSE OF THE PERFORATION: TAKING INTO CONSIDERATION THE AGE OF THE PATIENT, THE ALTERED ANATOMY OF THE PATIENT AND THE JUDGEMENT OF THE INDEPENDENT MEDICAL PROFESSIONALS, IT IS CONCLUDED THAT THE PERFORATION WAS MOST LIKELY CAUSED BY THE APPLICATION OF EXCESS FORCE TO THE DIGESTIVE TRACT WHILE INSERTING THE SCOPE.

    Description of Event or Problem · 0

    ON (B)(6) 2017, PATIENT UNDERWENT GALLSTONE REMOVAL IN A COMMON BILE DUCT AFTER ROUX-EN-Y RECONSTRUCTION. AFTER PANCREATIC DUCT CANNULATION, THERE WAS DIFFICULTY IN BILE DUCT CANNULATION. A PERFORATION OCCURRED WHEN TWISTING THE ENDOSCOPE TO GET A VIEW OF THE PAPILLA IN A LOOK-UP POSITION.

    Additional Manufacturer Narrative · 1

    ON 06/05/2017, THE DEVICE WAS INSPECTED AND NO FAULT WAS FOUND. THE PERFORATION LIKELY OCCURRED DUE TO THE ALTERED ANATOMY OF THE PATIENT AND AGE OF THE PATIENT. THE PHYSICIAN STATED THERE WAS NO EXCESS FORCE ADDED WHILE MANEUVERING THE ENDOSCOPE. THE PERFORATION OCCURRED WHILE THE BALLOON WAS DEFLATING AND A TWISTING MOTION WAS APPLIED TO THE ENDOSCOPE. DUE TO EXISTING (B)(6) PRACTICES IN CONNECTION WITH LOCAL FILINGS, THE SPECIFIC NAME AND LOCATION OF THE INITIAL REPORTER ARE NOT AVAILABLE. ALTHOUGH THE SUBJECT SCOPE MODEL EI-530BT, USED DURING THIS INCIDENT, IS NOT A DEVICE THAT IS MARKETED AND SOLD IN THE U.S., MODEL EN-580T IS A U.S. MODEL SIMILAR IN DESIGN.

    Description of Event or Problem · 1

    ON (B)(6) 2017, PATIENT UNDERWENT GALLSTONE REMOVAL IN A COMMON BILE DUCT AFTER ROUX-EN-Y RECONSTRUCTION. AFTER PANCREATIC DUCT CANNULATION, THERE WAS DIFFICULTY IN BILE DUCT CANNULATION. A PERFORATION OCCURRED WHEN TWISTING THE ENDOSCOPE TO GET A VIEW OF THE PAPILLA IN A LOOK-UP POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440797 FUJINON EI-580BT FDA FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE EI-580BT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other EPX-4450HD| EPX-4450HD| EPX-4450HD