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

Model Number UCR

Device Problem Corroded (1131)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoscopic carbon dioxide regulation unit had low pressure and not enough carbon dioxide (co2).Additionally, the tip was rusty, the hose could not be removed, gas outlet adapter of the front panel was rusty.This was observed prior to an unknown procedure.The procedure was completed but it is unknown whether the procedure was completed with the subject device or a similar one.There was no procedural delay.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction of ¿gas outlet adapter of the front panel was rusty.¿.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.There was a damaged front panel and top cover and the front and bottom chassis were rusty.There was component damage on the control board of the front panel.The device failed the primary and secondary leak test due to a faulty second decompressor, valve and separator unit.The tube connector was dirty inside.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the cause of the rusty gas outlet likely occurred from user handling of the device.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• 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: 13666816
• MDR Text Key: 296756632
• Report Number: 8010047-2022-03947
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• 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