MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOSCOPIC CO2 REGULATION UNIT

Model Number	UCR
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a screening colonoscopy, when angulating the scope, it would lock.The physician was thus unable to disengage during removal of a polyp, causing the colon to tear/perforate.It is unclear if this patient underwent any treatment.The physician stated that the colon was not insufflating during the procedure, and it was unclear if the insufflator malfunctioned or if there was a problem with the scope, or if it was something else.Additional information has been requested and pending information.The customer indicated 6 cases of perforations occurred.Thus, additional 4 cases are reported for perforation.2 patients had microperforations in the colon were treated.4 patients had surgeries: repair in 1 patient and hemicolectomy in 3 patients.
Event or Problem Description
This supplemental report is being submitted to provide correction to f6 date.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Common Device Name: CO2 REGULATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 20762011
• Report Number: 2429304-2024-0000466
• Device Sequence Number: 20930935
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 10/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COLONOVIDEOSCOPE, CF-H180AL, SN- (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male