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

Model Number	UCR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a colonoscopy procedure, the patient had a 2cm serosal tears at the cecum due to overinflation of carbon dioxide (co2) using this co2 regulation unit.An upright chest x-ray revealed a free intraperitoneal air, as per the physician.It was not a through and through but a damage to the wall of cecum due to overstretching.The patient was brought back to the operating room and a exploratory laparotomy, ileocecectomy were performed.The patient was then transferred to the intensive care unit (icu) and is currently stable.There were no further reports of patient harm.

• 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: 50178247
• Report Number: 2429304-2026-00108
• Device Sequence Number: 21303935
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026
• Report Date (Section F): 08/07/2026

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: 07/16/2026
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• 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; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/07/2026