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	Malfunction
Additional Manufacturer Narrative
The device was returned to fujifilm medical systems usa inc.(fmsu) for inspection.The inspection did not reveal any sharp edges or any other faults.If any additional relevant information is provided, a supplemental report will be submitted.
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; fmsu notified fujifilm corporation of the event on july 07, 2020.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: 10307493
• Report Number: 3001722928-2020-00011
• Device Sequence Number: 11605773
• Product Code: FDF
• UDI-Device Identifier: 14547410337393
• UDI-Public: (01)14547410337393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR