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

Model Number UHI-4

Device Problems False Alarm (1013); Failure to Power Up (1476)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.According to the evaluation, the following was found.Olympus repair center could confirm the reported phenomenon.Mainboard of the device required replacing.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

During laparoscopy, the user found that the device power was turned off.The health care professional of the user facility was using the insufflator to pump co2 into the patient's abdomen when this event occurred.Also, the warning of insufficient supply pressure of the device was alarmed although the co2 gas inlet was not empty.The user replaced the device with another device and completed the procedure.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) investigated the device and could reproduce the reported phenomenon.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc surmised that this phenomenon attributed to the failure main circuit board.The exact cause of the failure main circuit board could not be conclusively determined.Aging deterioration may have caused the defect because 5 years have passed since the device was manufactured.If significant additional information is received, 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: 11853451
• MDR Text Key: 263608065
• Report Number: 8010047-2021-06520
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1