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
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number: 2429304-2024-0000430.This report is related to (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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.Due to the perforation, the patient had to have a right hemicolectomy.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 multiple times but not received.
Additional Manufacturer Narrative
This report is being supplemented to provide information inadvertently left out (b5, h3, lm investigation, and device evaluation).The device was evaluated by olympus, and the reported malfunction was not reproduced.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, no defect was observed.Therefore, the root cause of the reported event could not be determined with the information received.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the procedure was diagnostic colonoscopy.There was no delay in the procedure and the procedure was completed with the same device.Additionally, the right hemicolectomy was not previously planned.

• 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
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20364315
• Report Number: 3002808148-2024-09588
• Device Sequence Number: 20547930
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K081173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVIS EXERA II COLONOVIDEOSCOPE: SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White