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 Abdominal Pain (1685); Burn(s) (1757)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

An olympus field service engineer (fse) reported on behalf of the customer an incident involving the high flow insufflation unit during a laparoscopic cholecystectomy case.It was noted that the carbon dioxide gas (co2) was supplied by the hospital pipe line system.After the surgery equipment was set to the patient, the megadyne electrosurgical energy unit was tested inside the abdominal cavity, and a spark was noted, which was decided as normal.The electrosurgical activation was continued then a "flash spark" happened with a lot of smoke.The physician removed everything from the patient, and one melting trocar was found.The co2 supply was switched from the pipe line to an individual tank.The physician released all remaining smoke and gas from the abdominal cavity then refilled and irrigated for damage investigation.The left side of the liver and some area of the stomach were burned.A gastroscopy was then performed to check for stomach perforation, which was negative.A liver function test was planned.The laparoscopic procedure was then resumed and completed successfully with the co2 tank supply.The procedure was prolonged for approximately 20 minutes with the patient under general anesthesia.The patient reported mild abdominal pain during the recovery period.The patient was evaluated about a week after the procedure and first-degree burns were found, which reportedly caused the stomach ache.No additional treatment was given for either the burn or the stomach ache.There was no further information received if the liver function test was performed or what the results were, if any.The patient was discharged from the hospital.The customer reportedly could not determine what caused the spark.The equipment was checked, and it was noted that the pressure inside and outside for the co2 pipeline was the same with the co2 release from the co2 tank.The fse also visited on site and checked the device, which was confirmed to be working properly and remained in use.

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 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported event could not be determined.However, the event was likely caused by a non-olympus electrosurgical knife.Olympus will continue to monitor field performance for this device.

• 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: 17248597
• MDR Text Key: 318344440
• Report Number: 3002808148-2023-06638
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MEGADYNE ELECTROSURGICAL UNIT
• Patient Outcome(s): Other; Required Intervention