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

Model Number UHI-4

Device Problems No Display/Image (1183); Excess Flow or Over-Infusion (1311); Pressure Problem (3012)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported, that the insufflation unit exhibited and error e03-excessive pressure when inflated, e04 - irregularity with the offset data and the front panel display disappeared.The issue occurred during preparation for use for an unspecified procedure.There were no reports of patient harm.

Manufacturer Narrative

The subject device was not returned to olympus for evaluation.The user facility was contacted to obtain additional information and to check the status of the subject device.The investigation is on going, and this report will be supplemented when new and relevant information becomes available later.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation corrected fields:d9.Additional information added to fields: h3 ,h6.The customer's allegation was not confirmed.The device evaluation found that the reported issue could not be reproduced.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it surmised that the phenomenon occurred due to faulty main board.However, the root cause could not be established.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: 18813014
• MDR Text Key: 337633391
• Report Number: 3002808148-2024-01938
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UY
• 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: 04/11/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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