MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device in this report was returned to omsc for evaluation.Omsc could not confirm the presence of water in the tube but there were traces of water in the tube.In addition omsc found traces of water in the tube inside the device, and that the tube could not be removed.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.There was no service record for the subject device.Six years or more have passed since the subject device was manufactured.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that the reported phenomenon was caused by the backflow of liquid into the device body because it is known that water in the water feed tank may flow into the device through the gas tube.Therefore, the following is described as a warning in the instructions for use of the subject device: ¿to prevent the water in the water feed tank from flowing into this unit through the gas tube, install this unit in a position as high as possible compared to the water feed tank.¿.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, there was water in the tube between the subject device and a water container.The subject device was replaced with a similar device and the endoscopic diagnosis was completed without using the subject device.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is to inform that upon further review, per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Initially, we determined that the event was mdr reportable due to a backflow of liquid from the water container into the unit co2 regulator (ucr), in which case we determined that it was a potential adverse event because of the risk for infection.Upon further investigation, it was found that liquid does not flow back into the ucr from the water container unless multiple situations occur simultaneously.There are no reports of situations occurring for this complaint.In addition, a component analysis was performed on the water droplet traces in the tube of the ucr at a similar complaint.The results of this component analysis detected silica and others that appeared to be derived from tap water, but no component that appeared to be body fluids were detected.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• 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: 11137810
• MDR Text Key: 238364702
• Report Number: 8010047-2021-01083
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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