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

Model Number	UCR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled "transverse versus longitudinal mucosal incision during poem for esophageal motility disorders: a randomized trial".Longitudinal incision is the commonly used incision for entry into the submucosal space during peroral endoscopic myotomy (poem) for esophageal motility disorders.Transverse incision is another alternative for entry and retrospective data suggest it has less operative time and chance of gas-related events.This was a single-center, randomized trial conducted at a (b)(6) hospital.Patients undergoing poem for esophageal motility disorders were randomized into group a (longitudinal incision) and group b (transverse incision).The primary objective was to compare the time needed for entry into the submucosal space.The secondary objectives were to compare the time needed to close the incision, number of clips required to close the incision, and development of gas-related events.The sample size was calculated as for a non-inferiority design using kelsey method.Sixty patients were randomized (30 in each group).On comparing the 2 types of incisions, there was no difference in entry time [3 (2, 5) vs 2 (1.75, 5) min, p = 0.399], closure time [7 (4, 13.5) vs 9 (6.75, 19) min, p = 0.155], and number of clips needed for closure [4 (4, 6) vs 5 (4, 7), p = 0.156].Additionally, the gas-related events were comparable between the 2 groups (capnoperitoneum needing aspiration¿5 vs 2, p = 0.228, and development of subcutaneous emphysema¿3 vs 1, p = 0.301).This randomized trial shows comparable entry time, closure time, number of clips needed to close the incision, and gas-related events between longitudinal and transverse incisions.Type of adverse events/number of patients event1: subcutaneous emphysema ((b)(4) cases).Event2: na for this device.Event3: capnoperitoneum ((b)(4) cases).Most of the adverse events were mild and were tackled during the procedure itself.Capnoperitoneum events required needle aspiration.
Additional Manufacturer Narrative
H6 health effect clinical code - no code selected to represent subutaneous emphysema and capnoperitoneum.The event date was reported as the publication date of the literature.This report is related to (b)(4).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the reported event is an accident, or a complication associated with a procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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: 20501767
• Report Number: 3002808148-2024-10211
• Device Sequence Number: 18252912
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Study,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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?: No
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/16/2025
• 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: DISPOSABLE DISTAL ATTACHMENT: LOT UNK; EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE: SN UNK; SINGLE USE ELECTROSURG HEMOSTATIC FORCEPS: LOT UNK; SINGLE USE ELECTROSURGICAL KNIFE: LOT UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown