MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The cause of the customer's experience can not be definitively determined at this time.This report will be updated upon completion of the investigation or should additional relevant information become available.This event has been reported by the importer on mdr# 2951238-2020-00515.

Event Description

It is reported an unstated period of time following a colon screening procedure using a evis exera iii xenon light source, the patient developed abdominal distention and severe abdominal discomfort-worse on the right.A post-procedure perforation was discovered.The patient was taken for an emergent exploratory laparotomy with abdominal irrigation and right hemicolectomy.The patient recovered and was discharged from the hospital (b)(6) 2020.It is the provider's opinion that the olympus clv-190 could have potentially caused or contributed to the event as the airflow was set on high.

Manufacturer Narrative

This report is being updated to provide investigation findings.The actual device was not returned to olympus for evaluation.A review of the device history record (dhr) for the complaint device confirmed there were no abnormalities in the manufacturing of this device.A physical evaluation of the complaint device could not be performed as the device was not returned to olympus.Conclusion: there was no abnormality with the device because there was no problem with the dhr.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10819151
• MDR Text Key: 216097028
• Report Number: 8010047-2020-08757
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 79