MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE

Model Number	ED-580XT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rn, gi lab manager.The scope was requested for return for instrument inspection.Fujifilm corporation conducted a reproduction experiment using the same model trocar and duodenoscope.It was found that if the distal end cap was either improperly attached, or the bending portion of the duodenoscope was not straight.The cap may get caught on the edge of the trocar and detach.The investigation is in progress.It should be noted that the operation manual indicates the insertion route as peroral, however, the endoscope was inserted using a trocar via surgical incision.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On july 07, 2020 fujifilm medical systems usa inc (fmsu) was informed that the distal end cap (dc-07d) prematurely detached from the distal end of a duodenoscope at the end of a procedure; fujifilm corporation was notified of the event on (b)(6) 2020.The procedure being performed was an endoscopic retrograde cholangio-pancreatography (ercp) for removal of gallstones from the lower third of the bile duct.The ercp was done laparoscopically with the scope being inserted through a non-fujifilm 15mm trocar via the abdomen.At the end of the procedure as the physician was withdrawing the scope, the distal end cap came off the scope and was observed to be stuck on to the trocar.The distal end cap was removed and discarded.The customer did not indicate any issues during attachment of the distal end cap prior to start of the procedure.This procedure was delayed an unspecified amount of time; however it did not result in any adverse issues for the patient and the procedure was completed successfully.This report is being submitted in abundance of caution.
Additional Manufacturer Narrative
Updated information is being provided in section h6 (type of investigation, investigation findings, investigation conclusions), h10 (narrative).The endoscope was returned to fujifilm medical systems u.S.A., inc (fmsu) on september 19, 2020, and the inspection was concluded on september 21, 2020.The results of the inspection did not reveal any abnormality that could have led to the failure of distal cap becoming detached.The operation manual indicates the insertion route as peroral, however the endoscope was inserted using a trocar via surgical incision.The scope will be serviced according to device specifications and returned for clinical use.If any additional relevant information is provided, a supplemental report will be submitted.

• 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: 10542398
• Report Number: 3001722928-2020-00014
• Device Sequence Number: 15514801
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERSAONE TROCAR - COVIDIEN