MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problems Display or Visual Feedback Problem (1184); Connection Problem (2900)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

The user facility reported that when preparing the subject device for use during an unidentified procedure, the device was not working.An olympus field service engineer inspected the device and observed the front panel screen was blacked out when the device was powered on, and only the power led (light emitting diode) indicator was lit.There was no alarm or beep generated.There was no report of patient or user injury due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

The suspect device was returned to an olympus service center for further evaluation.Inspection and testing of the device found only part of the indicator light on the front panel would light up when the power was turned on, due to a printed circuit board failure.Additionally, it was observed that there was a gas leak from the connector unit due to failure of the connector unit.Service also found the surface appearance of the device demonstrated wear and scratches.The investigation is ongoing.Therefore; a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the approved final investigation.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 definitive root cause of the faulty circuit board and the leak could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

The event occurred at the time of general routine inspection of equipment before using it and due to the issues identified our field engineer was informed and called upon.

Manufacturer Narrative

This report is being supplemented to provide additional information for b5 of the initial medwatch.The event occurred at the time of general routine inspection of equipment before using it and due to the issues identified our field engineer was informed and called upon.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14031645
• MDR Text Key: 298404786
• Report Number: 8010047-2022-05859
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122180
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• 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: 03/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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