MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. INSUFFLATOR "UHI-3", 100-240 V

Model Number A90120A

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.Over 13 years have passed since the subject device was manufactured.Based on the results of the investigation, it is likely the event occurred due to the following factors related to normal deterioration from age: main board malfunction; faulty front panel unit; faulty power supply board.

Event Description

During annual preventive inspection, the olympus field service engineer found the buttons on the front panel were periodically non-responsive.There was no patient involvement.

• Brand Name: INSUFFLATOR "UHI-3", 100-240 V
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11186937
• MDR Text Key: 228009061
• Report Number: 8010047-2021-01569
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2021

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: A90120A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1