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

Model Number UHI-3

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

The customer returned the unit and accessories maj-1080, gas hose, gas tubes and power cord.Further inspection found the bottom chassis was rusty.All the other functions of the uhi-3 unit were normal.Minor scratches were noted on the top cover and front panel.

Event Description

During a standard inspection of a customer returned asset, the uhi-3 unit was powered on without co2 gas inside and the (2) leds of the bar graph for measuring pressure illuminated at the same time due to faulty main board.The customer did not report any problems associated with the device and there was no patient/user injury or harm reported to olympus.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible cause for the reported event are presumed as follows: two pressure measurement rods lighted up at the same time.The cause of the indicated phenomenon is that the main board has failed.The cause of the failure of the main board could not be identified.It is a guess, but since it has been 13 years since it was manufactured, it is thought that it is due to deterioration over time.As a result of checking the dhr, it was confirmed that there were no manufacturing abnormalities, special hires, or variations.

• 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: 12074948
• MDR Text Key: 258620685
• Report Number: 8010047-2021-08061
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140280
• UDI-Public: 04953170140280
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1