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

Model Number UHI-4

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that while using insufflation unit, the fuse holder was missing.The issue occurred during preparation for use.There was no patient harm associated with the event.

Manufacturer Narrative

To date, the device is expected to be returned for evaluation, but has not yet been received.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any 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.Based on the results of the investigation, the customer¿s allegation was confirmed.It was determined that the reported event was failure of power supply due to blown fuse, and it has nothing to do with insufflation, hence, it can be stated that over pressure did not occur.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide third-party physical device evaluation information.See updated sections b5, d8, d9, g3, h3, h4, h6, and h10.The device was returned and evaluated by a third-party distributor, and the customer¿s allegation was confirmed.The reason for the unit being sent to olympus was that the unit kept blowing fuses and suspected the power supply to be faulty.The third-party distributor did not have a power supply in stock to test with to see if the issue would be resolved.Additional issues were identified during the device evaluation: missing fuses and fuse holders, and the power inlet socket (line filter) replacement.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information becomes available.

Event Description

Additional information was supplied buy the customer.The subject device unit was not used in procedures.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.All defects found during investigation: power of the device does not turn on due to faulty power switch.Power of the device does not turn on due to faulty power circuits.Connector on the main board is damaged likely due to faulty printed circuit board.Fuse holder is missing the definitive root causes were unable to be determined any further.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: 18028310
• MDR Text Key: 326801312
• Report Number: 3002808148-2023-11962
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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