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

Model Number	UCR
Medical Device Problem Codes	Increase in Pressure (1491); Pumping Problem (3016)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 in 2 cases of a gastric peroral endoscopic myotomy (poem) procedure, the customer was utilizing ucr endoscopic co2 regulator unit (with maj-2047 -hdtv cable).Prior to performing the procedure, co2 was confirmed running.Mid-procedure, it was reported air was running unintentionally that pumped into the patients developing pneumothorax.The patients were admitted because of the air/co2 issue and medical intervention was undertaken/additional treatment to drain and rectify pneumothorax.The patients are reported to have survived.This event is for second procedure undertaken.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to field b5, h3, and h4.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, it is likely that the reported event occurred due to the setting of cv-1500 (video processor) was switched to air from co2.Additionally, it could be confirmed that there was no abnormality on the performance of ucr (endoscopic co2 regulation unit).However, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported by the facility co2 flow was switched to air flow unintentionally occurred during test phase and there was no patient harm.This event is for procedure three.

• 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: 19529188
• Report Number: 3002808148-2024-05381
• Device Sequence Number: 12688924
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 06/03/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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 X1 VIDEO SYSTEM CENTER, CV-1500, SN (B)(6).; MAJ-2047, HDTV CABLE, SN UNK
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown