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

Model Number UHI-4

Device Problems Crack (1135); Display or Visual Feedback Problem (1184); Intermittent Loss of Power (4016)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was not able to be confirmed.In addition to the findings of the damaged front panel and cracking of the connecting tube, the front chassis and damper were found to be damaged as well.The investigation is ongoing and follow up with the user facility is currently being performed.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 that while using the high flow insufflation unit, the device started beeping and kept turning on and off intermittently during the middle of a therapeutic procedure.No other devices were involved in this event.The procedure was completed with a similar device (uhi-4, serial number (b)(4)).There was a delay of ten (10) minutes while the patient was under general anesthesia while the device was switched out.The device was returned and evaluated, and it was found that some of the led (light-emitting diodes) did not work due to a damaged front panel.The connecting tube was also found to be cracked.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the device beeping and intermittently turning off was unable to be identified.Additionally, it¿s likely some of the leds were not working because the front panel was damaged.The root cause of the front panel damage was unable to be identified.Furthermore, it¿s likely the connecting tube was cracked due to stress that was applied to the tube.The root cause of this event was unable to be identified.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15417792
• MDR Text Key: 306168144
• Report Number: 3002808148-2022-01994
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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