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: 2429304-2024-0000468.A3a: male was inadvertently selected and could not unselected.The evaluation of the event 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.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.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304 -2024 -0000468.This supplemental report is being submitted to provide correction to g3 date.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.One unit of ucr (endoscopic co2 regulation unit) was returned to olympus and the inspection was conducted.As a result of that, no abnormality of the device was recognized and the phenomenon was not reproduced per the returned unit.The device history record was unable to be reviewed for this specific device since the serial number was not provided for this complaint.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a specific root cause of the reported event could not be determined with the information received.Olympus will continue to monitor field performance for this device.

• 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: 20765693
• Report Number: 3002808148-2024-11122
• Device Sequence Number: 9493500
• 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,Followup
• Report Date (Section B): 02/20/2025

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?: No
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 02/18/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/03/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: COLONOVIDEOSCOPE, CF-H180AL, (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male