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

Model Number UHI-4

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the alarm sound is generated and the front panel is turned off.The device was not inspected for usage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported, the high flow insufflation unit had the connection tube come loose.When the connection was repaired, gas was being supplied, but the alarm kept ringing.When the gas supply was temporarily stopped, the power was turned off; 7 all segment displays had disappeared.When the power was turned back on, the system recovered and the surgery was completed, but the cumulative gas flow rate had been reset.The event occurred during a laparoscopic cholecystectomy therapeutic procedure.The procedure was completed using the same set of equipment.There was no patient harm associated with the event.Related patient identifiers: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 eight years since the subject device was manufactured.Based on the results of the investigation, the tubing may have been clogged or the over-pressure alarm sounded immediately before the operation stopped.However, it is likely that the main circuit board malfunctioned because the front panel indication disappeared and the power had been turned off.It is highly probably that the failure of the sensor on the main circuit board caused the alarm to sound, the operation to stop, the front-panel indication to disappear, and the power supply to the product be turned off.However, the root cause of the events could not be determined.Olympus will continue to monitor the field performance of 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: 18580108
• MDR Text Key: 334843892
• Report Number: 3002808148-2024-00761
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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