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

Model Number UHI-4

Device Problems Electrical /Electronic Property Problem (1198); No Flow (2991)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The evaluation is in progress currently.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 from the user that the subject device made the alarm and all front panel indicators lit out and the subject device was stopped during the unspecified therapeutic procedure.At that time, only the lamp of the power switch lit up.The user turned off and on the subject device then it was worked, and the intended procedure completed with the subject device.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) checked the subject device for evaluation but could not duplicate the reported phenomenon.The exterior of the subject device had no abnormality.There was also no abnormality when the subject device was operated with following the instruction manual.At the investigation stage, omsc confirmed that the reported phenomenon occurred when the air supply of the subject device was continued.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based on the investigation, omsc concluded that the reported phenomenon was occurred due to the failure of the pressure sensor on the main board.It could not be identified the cause of the failure of the pressure sensor.It was surmised that it was occurred due to the aging deterioration with passing more than 8 years since manufacturing the subject device.[the order of occurrence] the alarm and display of the subject device went off when the pressure sensor failed, and all operations stopped because the display went off.If additional information becomes available, this report will be supplemented.

• 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: 11829865
• MDR Text Key: 268151006
• Report Number: 8010047-2021-06345
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/15/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1