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

Model Number UHI-4

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a repair at olympus (b)(4), it was found that when the subject device was turned on the indicators on the front panel of the subject device were not lit up and the alarm sounds were generated.This phenomenon was occurred after new main circuit board was installed into the subject device, but another main circuit board was installed, the issue did not occur.There was no abnormality on the exterior of the main circuit board.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus china.The main circuit board of the subject device was returned to olympus medical systems corp.(omsc) for investigation.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Based on the investigation, this phenomenon was attributed to 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 circuit board is presumed to be due to any of the following process errors.- 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.- because foreign matter (epoxy) had adhered to the mounting of the component due to a mistake, the wires inside the pressure-sensor had peeled off due to adherence of the foreign matter (epoxy).

• 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: 11337228
• MDR Text Key: 232798995
• Report Number: 8010047-2021-02746
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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: No Information
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1