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

Model Number UHI-4

Device Problems Display or Visual Feedback Problem (1184); Infusion or Flow Problem (2964); Audible Prompt/Feedback Problem (4020)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon "all indicators on the front panel turned off and the alarm continued to sound" was duplicated due to the failure of the main circuit board.However the reported phenomenon "the actual cavity pressure was insufficient compared to showing of the cavity pressure indicator" was not duplicated.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 during the preparation for use, all indicators on the front panel turned off and the alarm continued to sound when overpressure continued.The user cycled the power of the subject device and handled the subject device.Also the user felt that the actual cavity pressure was insufficient compared to showing of the cavity pressure indicator.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus service operation repair center (sorc), omsc concluded that the reported phenomenon was attributed to the following.- "all indicators on the front panel turned off and the alarm continued to sound" this phenomenon was attributed to the failure of the main circuit board, which might be caused by aging deterioration because eight years and seven months had passed from the subject device had been manufactured.- "the actual cavity pressure was insufficient compared to showing of the cavity pressure indicator" the exact cause of this phenomenon could not be conclusively determined.However, there was the possibility that this phenomenon was attributed to the failure of the main circuit board or a factor other than the subject device.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: 12329679
• MDR Text Key: 266851276
• Report Number: 8010047-2021-10320
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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: Other
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1