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

Model Number UHI-4

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The customer reported to olympus that the high flow insufflation unit was powering off in the middle of an unspecified therapeutic procedure.There was no report of patient harm associated with the event.

Manufacturer Narrative

Additional information has been requested regarding this event.To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, (h3) device evaluated by manufacturer was updated to no and (h4) device manufacturer date was added.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, as the device was not returned for evaluation, the reported issue could not be verified, and 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: 18562613
• MDR Text Key: 333464301
• Report Number: 3002808148-2024-00671
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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