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

Model Number UHI-4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during an elective laparoscopic cholecystectomy, the patient was intubated without incident and when the abdomen was insufflated with the high flow insufflation unit, the patient became bradycardic with a heart rate (hr) of 50, and was treated with two doses of atropine (600 mcg each, total of 1200mcg).The hr continued to drop from 20 to 10 with no output and the patient went into pulseless electrical activity (pea) arrest.The co2 insufflation gases (administered at a rate of 4 l/min to a pressure of 12mmhg) had been turned off at the first sign of bradycardia.The second anesthetist started cardiopulmonary resuscitation (cpr) while the primary anesthetist managed the airway.Cpr was performed for less than a minute and the patient was stabilized.The surgery was abandoned, and the wound was sutured closed.The patient was extubated and moved to recovery and subsequently the emergency department (ed) for monitoring.The blood results taken in recovery were unremarkable.There is no information linking the insufflator to the event and nothing to confirm there was over pressure.There was no malfunction of the device reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the subject device was not returned to olympus for a physical evaluation and the cause of the patient adverse event could not be determined based on the information provided.Therefore, the root cause could not be identified.This supplemental report includes additional information received from the customer.B5 has been updated accordingly.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the device (uhi-4) was set to normal cavity mode, and the flow rate setting was likely set to high.The relief mode setting was off, and no other gas source was used (other than the uhi-4).At the time of the incident, the pinch valve did not exhaust smoke, and the smoke evacuation suction tube was not connected.There was no indication that overpressure occurred during the procedure.Although the reporter stated that there was no overpressure warning alarm, overpressure warning light alarm, or tube clogging warning alarm noted during the incident, the device alarmed often.In addition, there was no obvious distension of the patient¿s abdomen observed.Furthermore, the device (uhi-4) was used after this reported incident with no issues.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: 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: 18145685
• MDR Text Key: 328225042
• Report Number: 3002808148-2023-12949
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0075-2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female