MAUDE Adverse Event Report: FUJIFILM CORPORATION EC-600HL; COLONOSCOPE AND ACCESSORIES

Model Number	EC-600HL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Something appears to be lodged in the forward water jet of the endoscope forcing a bifurcated stream of water instead of one continual stream.This caused the pressure to be increased causing a mucosal abrasion in the right part of the colon.Doctor was unsure if the bifurcated stream was apparent prior to the case, or happened interprocedurally.If prior to the case, then this could be a cross contamination issue.During an internal review, it was identified that this event was not reported to fda by the importer as required by 21 cfr 803.This event was reported to the manufacturer on 07/26/2018.The manufacturer reported this event to fda under report # 3001722928-2018-00057.

• Brand Name: EC-600HL
• Common Device Name: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 12445787
• Report Number: 1000513161-2021-00012
• Device Sequence Number: 14348082
• Product Code: FDF
• UDI-Device Identifier: 04547410330212
• UDI-Public: (01)04547410330212(11)170301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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-600HL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2021
• 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: Other