MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT

Model Number	UHI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported that when using a high flow insufflation unit, the patient¿s heartrate dropped from 60 to 30 bpm.The event occurred during the therapeutic procedure (laparoscopic hysterectomy) and was at a setting of 15mmhg.The setting was lowered to 12mmhg and after resting for 5 minutes, 4 instruments were moved, and the patient¿s heart rate dropped again.The procedure was terminated since the heart rate fluctuated.There was no change when switching from bipolar to monopolar instruments.Additional information regarding the event was requested but not provided at this time.
Event or Problem Description
The indication for the procedure was suspected ca corpus.It was not an urgent case but delayed a surgical resection of tumor.It did not cause a serious deterioration in the patient's state of health.There were no relevant pre-existing conditions for the patient.Currently, the patient has had a private cardiac workup including cardiac mri and holter done and results are normal.The cancelled case has been rescheduled.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and no abnormalities were observed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 9 years since the subject device was manufactured.Based on the results of the investigation, olympus did not identify any device abnormalities, nor any indication that the device caused the patient's reported bradycardia.The procedure was cancelled/treatment delayed due to actions taken to address the patient¿s bradycardia.However, the root cause of the event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Common Device Name: HIGH FLOW INSUFFLATION 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: 18261517
• Report Number: 3002808148-2023-13690
• Device Sequence Number: 20755978
• Product Code: HIF
• UDI-Device Identifier: 04953170140280
• UDI-Public: 04953170140280
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K014166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2024

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: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/06/2023; 02/09/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/06/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian