MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE

Model Number ED-580XT

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 9644751
• MDR Text Key: 189913619
• Report Number: 1000513161-2020-00001
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 03/04/2020
• Distributor Facility Aware Date: 01/04/2020
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR