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

Model Number UCR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

The user informed olympus that some patients suffered from barotrauma.The user noticed the complication when they observed some damages on the mucosa that might be consistent with barotrauma during procedures using either ucr serial number (b)(4).The exact number of affected patients is unknown, but at least 5 patients were involved.The user facility is carrying out investigation to see if the root cause of the barotrauma was due to excessive insufflation using co2 at high pressure.Olympus representative has confirmed that the devices were connected to the wall where there are internal co2 pipes, not to a cylinder.Olympus medical systems corp.(omsc) is submitting five medical device reports according to the number of potentially injured patients.This is 2nd of 5 reports.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for evaluation and the repair center was unable to confirm the customer's complaint.The device flow rate and pressure were within the standard specification.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely there is no problem with the subject device and that the adverse event occurred because of other equipment (such as the connecting equipment or connection condition).

• 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
• MDR Report Key: 11026001
• MDR Text Key: 223594132
• Report Number: 8010047-2020-10553
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other