MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE

Model Number	ED-580XT
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(date of birth): unknown.Initial reporter: rn, gi lab manager.During follow-up and on site visit by the fujifilm clinical specialists, it was found that the non-fujifilm sphincterotome came out of the scope to the right instead of straight.In addition the staff indicated that after attaching the cap a small gap was noticed between the distal cap and the endoscope.The fujifilm clinical specialists reviewed several procedures and provided proper instruction to the staff.If any additional relevant information is provided, a supplemental report will be submitted.(b)(4).
Event or Problem Description
On 04 jan 2020 fujifilm medical systems u.S.A., inc (fmsu) was informed that the distal end cap (dc-07d) prematurely detached from the distal end of a duodenoscope during a procedure.The procedure was an ercp (endoscopic retrograde cholangio-pancreatography) on a patient with obstructive jaundice.In addition to the duodenoscope, it was noted that an et tube (endotracheal tube), biteblock and sphincterotome were used, all non-fujifilm products.The procedure was completed with no issues noted, however once the endoscope was taken to the cath lab it was noticed that the removable distal cap had come off.In order to locate the missing distal cap fluoroscopy imaging of the patient's digestive tract was requested; imaging did not locate the cap in the digestive tract.The physician checked the patient's oral cavity and located the missing cap in the back of the patient's mouth.The physician was able to remove the distal cap from the patient; distal end cap was discarded by the anesthesiologist.The physician felt that due to the fact that an et tube (endotracheal tube) was used during this procedure they did not think there was much risk.Fmsu requested return of the duodenoscope for inspection.This event caused a delay of about 20 minutes; however it did not result in any adverse issues for the patient.The procedure was successfully completed and the patient was discharged several days later.There was no injury or death associated with this case.This report is being submitted in abundance of caution.
Additional Manufacturer Narrative
Date of birth)-: unknown.Occupation: rn, gi lab manager.During follow-up and on site visit by the fujifilm clinical specialists, it was found that the non-fujifilm sphincterotome came out of the scope to the right instead of straight.In addition the staff indicated that after attaching the cap a small gap was noticed between the distal cap and the endoscope.The fujifilm clinical specialists reviewed several procedures and provided proper instruction to the staff.If any additional relevant information is provided, a supplemental report will be submitted.Ref: internal complaint number (b)(4).On 26 feb 2020 the fda requested that fmsu submit a follow up report to correct the device problem code.(b)(4).If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(4) 2020 fujifilm medical systems u.S.A., inc (fmsu) was informed that the distal end cap (dc-07d) prematurely detached from the distal end of a duodenoscope during a procedure.The procedure was an ercp (endoscopic retrograde cholangio-pancreatography) on a patient with obstructive jaundice.In addition to the duodenoscope, it was noted that an et tube (endotracheal tube), biteblock and sphincterotome were used, all non-fujifilm products.The procedure was completed with no issues noted, however once the endoscope was taken to the cath lab it was noticed that the removable distal cap had come off.In order to locate the missing distal cap fluoroscopy imaging of the patient's digestive tract was requested; imaging did not locate the cap in the digestive tract.The physician checked the patient's oral cavity and located the missing cap in the back of the patient's mouth.The physician was able to remove the distal cap from the patient; distal end cap was discarded by the anesthesiologist.The physician felt that due to the fact that an et tube (endotracheal tube) was used during this procedure they did not think there was much risk.Fmsu requested return of the duodenoscope for inspection.This event caused a delay of about 20 minutes; however it did not result in any adverse issues for the patient.The procedure was successfully completed and the patient was discharged several days later.There was no injury or death associated with this case.This report is being submitted in abundance of caution.

• Brand Name: FUJIFILM DUODENOSCOPE
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 9644751
• Report Number: 1000513161-2020-00001
• Device Sequence Number: 3143253
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ED-580XT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2020
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Date Report Sent to FDA: 03/04/2020