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

Model Number UHI-3

Device Problem Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The evaluation found that there was a decrease in pressure from the unit.The investigation is still ongoing, and this report will be supplemented when new information becomes available.An olympus (b)(4) capa has been opened to manage the actions related to remediation of this late mdr reporting.

Event Description

The service center was informed that a leak was noted on the unit¿s regulator valve.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and device evaluation results.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: since more than 15 years have passed since the product was manufactured, it is presumed that it occurred due to wear caused by aging deterioration.

• 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: 10951686
• MDR Text Key: 226702054
• Report Number: 8010047-2020-09869
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• 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: 09/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1