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

Model Number CLV-190

Device Problems Naturally Worn (2988); Scratched Material (3020)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted to report the event described by the customer and the investigation findings.The device referenced in this report has been returned to olympus for evaluation.Physical evaluation of the complaint device reveals: the user's report is not confirmed.Air, water and suction were all checked and all were found to be within specifications.The housing has scratches on the top cover.The high intensity mode is not working due to worn out scope socket and slider switch.The olympus lamp life meter is reading over 500 hours, lamp expired, and lamp has burn mark present.The device history record (dhr) for the complaint device was reviewed and it was confirmed that there were no anomalies were noted in the manufacture of the device, and it was shipped within specifications.Conclusion: based on the investigation findings, the root causes of the reported event are determined to be: since the device's air, water., and suction functions were tested, and all found to be within specifications, it was determined that the reported issue was not due to a device malfunction.More than five years have passed since the device was manufactured.The slider switch and output connector were worn out due to repeated use for a long period of time.The lamp is expired and determined to be past its service life.

Event Description

It is reported during a diagnostic colonoscopy using an evis exera iii xenon light source, when physician reached the cecum, it was noted that the patient had experienced barotrauma.The patient required no medical or surgical intervention as a result of this occurrence.The patient was discharged home as planned with no additional consequences reported.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11310973
• MDR Text Key: 233825726
• Report Number: 8010047-2021-02509
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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