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
This supplemental report is being submitted to provide correction to f6 date.
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 micro-perforations in the colon were treated.4 patients had surgeries: repair in 1 patient and hemicolectomy in 3 patients.

• 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: 20762106
• Report Number: 2429304-2024-0000470
• Device Sequence Number: 15559102
• Product Code: HIF
• UDI-Device Identifier: 04953170239748
• UDI-Public: 04953170239748
• 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