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

Model Number UHI-4

Device Problem Gas Output Problem (1266)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H9 correction and removal number: 3002808148-10/09/2023-001-c the device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the high flow insufflation unit was pumping carbon dioxide frequently throughout a laparoscopic inguinal hernia repair.The insufflation unit pressure was set at 15mmhg (low pressure).The indicated pressure for insufflation was 12 to 15mmhg.The pressure was reported to be adequate, but the insufflator was constantly pumping.There was no overpressure warning.The procedure was completed using this same device.Reportedly, the patient developed mild subcutaneous emphysema.The customer reported at the time they did not fault this to the insufflation unit but are unsure.No treatment was required, and the patient recovered well.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer later provided they are currently using suction tubing for our smoke evacuation so there is potential for leakage if the port is not closed when not being used.Not all physicians use the insufflation needles.It was also stated the co2 pumps throughout the entire case.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the customer's complaint was not confirmed.Therefore, the root cause of the reported event is unable to be determined.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: 18926934
• MDR Text Key: 337950395
• Report Number: 3002808148-2024-02539
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Reporter Occupation: Nurse
• Remedial Action: Relabeling
• 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: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: H10 FOR C&R NUMBER.
• Patient Sequence Number: 1
• Treatment: INSUFFLATION TUBING SET BARB 7-510-32; XCEL BLADLESS 5MM TROCAR #2B5LT