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

Model Number UCR

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

It is reported during a colonoscopy using an endoscopic co2 regulation unit with a h190 scope, the patient experienced barotrauma.The patient experienced no ill effects during or after the procedure related to the barotrauma and required no medical or surgical intervention as a result.The customer reported they been monitoring this equipment and discussing with the physicians and there have not been any new concerns.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.Physical evaluation of the suspect device could not be conducted as the device was not returned to olympus.There were no identified abnormalities in the manufacturing of the suspect device.Conclusions: the definitive cause of the reported event could no be established.Based on the available information it is presume it was likely caused by an increase in the pressure inside the body.We couldn't identify the cause of the increase in the pressure inside the body, but we presume that it was likely caused by the influence of factors other than the device (patient environment, usage situation).

• 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: 11790098
• MDR Text Key: 280508444
• Report Number: 8010047-2021-05984
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239748
• UDI-Public: 04953170239748
• Combination Product (y/n): N
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: H190 SCOPE