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

Model Number UHI-4

Device Problem Intermittent Loss of Power (4016)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the 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 has intermittent power / restarts.The issue was observed during routine maintenance.No patient or procedure was involved.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Front panel goes off, an alarm sounds, and it is not operable.Based on the results of the investigation it was confirmed the issue was caused by a faulty printed circuit board.However, the specific cause of the faulty printed circuit board was not established at this time.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: 18790356
• MDR Text Key: 336402069
• Report Number: 3002808148-2024-01825
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: PA
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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: 02/21/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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