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

Model Number CLV-190

Device Problem Missing Information (4053)

Patient Problems Injury (2348); Bowel Perforation (2668); Patient Problem/Medical Problem (2688)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

As the device was not returned for evaluation, we are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

Event Description

A user facility reported a patient injury during a diagnostic procedure.The patient's colon was perforated during a colonoscopy using a xenon light source.Emergency surgery was performed on the patient to correct the perforation.The surgery was completed successfully and the patient was discharged with no other problems.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A loaner has been sent to the user facility, however the subject device has not yet been evaluated / returned yet.Based on the results of the investigation, it is likely the phenomenon occurred because of too much air in the body cavity.It is difficult to find a causal relationship between the perforation and a clv-190 light source malfunction.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

• 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: 10898376
• MDR Text Key: 218499050
• Report Number: 8010047-2020-09411
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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?: No
• 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: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention