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

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

The user reported that the device beeped on startup.The user replaced the device with a similar device and completed the procedure.According to the inspection, the main circuit board had a failure and one of the screws on the housing was broken.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This report is being supplemented to provided additional information based on the legal manufacturer¿s final investigation.The following sections were updated: a1, d4, d10, g7, h2, h4, h6, and h10.Based on the legal manufacturer¿s investigation, the dhr was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.An olympus field service engineer (fse) was dispatched to the user facility and confirmed the reported issues.During the inspection, it was found that the main board was faulty, which caused an alarm.It was also noted that one of the screws on the housing is broken.The cause of the issue was determined to be the failure of the pressure sensor mounted on the main circuit board.The cause of the failure of the pressure sensor mounted on the main board appears to be that oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to the oxidation corrosion.In addition, foreign matter (epoxy) was adhered due to a mounting mistake of the part on the board.Because of the adherence of the foreign matter (epoxy), the wiring inside the pressure sensor was peeled off.When confirming the contents in the instruction manual regarding the indication phenomenon, the following was described.There were following descriptions in 7.1 "troubleshooting guide".·problem: all leds are turned off.·possible cause: an error is detected in the internal circuitry of this product.

• 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
• MDR Report Key: 10934234
• MDR Text Key: 226359908
• Report Number: 8010047-2020-09724
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1