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

Model Number UHI-3

Device Problems Leak/Splash (1354); No Device Output (1435)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported, the high flow insufflation unit panel was blinking.The issue occurred during an unspecified procedure.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned, and the evaluation found front panel was blinking due to defective main board.Additionally, it was found the gas was leaking from the electrical flow unit due to faulty electric flow unit.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.   new information added on fields: h4 and h6.Correction on fields: b5, d5 and e1.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.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that front panel blinks occurred due to defective main board.Additionally, gas leakage occurred due to defective electric flow unit.Olympus will continue to monitor field performance for this device. .

Event Description

The front panel blinks issue was found during general routine inspection.

• 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: 18902844
• MDR Text Key: 337693915
• Report Number: 3002808148-2024-02408
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2013
• 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