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

Model Number UHI-4

Device Problem Failure to Power Up (1476)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the high flow insufflation unit exhibited wetness, did not switch on, and the display did not light due to a defective power supply board and front panel respectively.The event was found during preparation for use for an unknown procedure.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 (company representative should be blank in the initial medwatch).Additional information added to field h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, the power of the device cannot be turned on, likely due to the failure of the power board, and the display is not lit, likely due to the failure of the front panel.However, a definitive root cause could not 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: 19105657
• MDR Text Key: 340905886
• Report Number: 3002808148-2024-03491
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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: 04/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• 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