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

Model Number UHI-4

Device Problems Medical Gas Supply Problem (2985); Noise, Audible (3273)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the reported event could not be confirmed.During evaluation, the air supply of the 1st regulator unit (b)(6) was found to be insufficient due to an immersed tube.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

The customer reported to olympus an abnormal sound inside of the high flow insufflation unit.The issue was found during preparation for use for a therapeutic, laparoscopy procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Event Description

There was no delay as a result of the reported event.The patient was not under anesthesia, as the reported malfunction occurred during preparation for the surgery.

Manufacturer Narrative

This report is being supplemented to provide corrections, and additional information based on the legal manufacturer's investigation.B5, and h6 have been corrected.Additionally, g3 of the initial medwatch should have been 28 dec, 2023 and not 21 dec, 2023 as initially reported.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine years since the subject device was manufactured.Based on the results of the investigation, the customer reported malfunction was most likely due to immersion in the tube.However, the root cause of the event 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: 18507302
• MDR Text Key: 333213727
• Report Number: 3002808148-2024-00434
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/21/2024

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: 12/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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