MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO COLONOSCOPE; VIDEO ENDOSCOPE

Model Number	EC-600WL V2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, and race: unknown.If any additional relevant information is provided, a supplemental report will be submitted.Ref: internal complaint number (b)(4).
Event or Problem Description
On july 01, 2020 fujifilm medical systems usa inc (fmsu) was informed that during a colonoscopy procedure for diagnostic purposes a tear occurred in the patient's colon.This occurred during the final stages of the procedure, the doctor retroflexed the scope in the colon which led to the tear.The doctor applied a medical clip to the tear, which will be expelled with the patient's bowel movement within the next month once the tear has healed.The patient was released from the endoscopy center after the procedure was completed.The scope was taken out of use after the procedure was completed.The doctor believed that there was a sharp edge at the distal end which led to the tear in the patient.However after further inspection of the colonoscopy scope, which was inspected by the lead endoscopy technician, there was no sign of any sharp edges.The technician did not believe that this was a user error; however there was also no proof to suggest otherwise.There was no death or serious injury associated with this event; this report is being submitted in abundance of caution.

• Brand Name: FUJIFILM VIDEO COLONOSCOPE
• Common Device Name: VIDEO ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 10307554
• Report Number: 1000513161-2020-00003
• Device Sequence Number: 10963675
• Product Code: FDF
• UDI-Device Identifier: 14547410337393
• UDI-Public: (01)14547410337393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020
• Report Date (Section F): 07/22/2020

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: EC-600WL V2
• 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: 07/01/2020
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2020
• 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: 59 YR
• Date Report Sent to FDA: 07/22/2020