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

Model Number UHI-4

Device Problems Audible Prompt/Feedback Problem (4020); No Visual Prompts/Feedback (4021)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported, the high flow insufflation unit stopped working and a buzzer started switching off and on.The issue occurred twenty minutes into a diagnostic laparoscopic hysterectomy procedure.The unit worked as expected for the next twenty minutes.The procedure was completed with no further issues.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and the evaluation found error code e03 excessive pressure when inflated-pressure sensor abnormality, due to a faulty main board, where the display would sometimes go dark and produce sound.Should additional relevant information become available, a supplemental report will be submitted.Complete establishment address: (b)(6).

Event Description

It was reported that the device¿s insufflation pressure setting was 15mmhg at the time of the event.The indication of insufflation pressure was stable.The flow rate setting was high, and the relief mode setting was off.There was no other gas source (other than the high flow insufflation unit) used.Smoke evacuation was not used, and the smoke evacuation suction tube was not connected.Also, the tube did not clog, nor alarm for clogging.Furthermore, it was confirmed that overpressure did not occur during the procedure.The intra-abdominal pressure was not high, and regarding distention, the patient¿s abdomen was reportedly ¿good.¿.

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, it was determined that the reported defect occurred due to the failure of the main board.However, the root cause of the reported event could not be determined.This supplemental report includes a correction to a2, a4, b5, d10, and g2 to provide information that was inadvertently not included in the initial medwatch.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: 18790553
• MDR Text Key: 337463357
• Report Number: 3002808148-2024-01828
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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: 02/19/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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: OLYMPUS TUBING; UNSPECIFIED DISPOSABLE TROCARS
• Patient Age: 65 YR
• Patient Weight: 70 KG