MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA EVIS EXERA II XENON LIGHT SOURCE

Model Number CLV-180

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

Patient Problem Perforation (2001)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the returned device: corrosion on the bottom chassis.The output socket air joint is worn out.The lamp ignition was set on manual and lamp life read 400 hours.There is excessive thermal grease on the xenon lamp and its light intensity reading at 250lux (brightness of lamp to be replaced at 450 max).All the front panel buttons were checked and passed functional inspection.There is also no problem found with the turret runaway detection, pump pressure, scope detection, and emergency lamp.The light source was then checked with our test scope and video processor cv-180.The brightness is adequate; iris blade, white light are working properly.Furthermore, the air output for each mode was also measured by using our test air flow meter and met the specifications.Here are the results: locked pressure when the air feeding was set to high, the pump pressure was 48 kpa (standard 53.9 kpa or lower).When the air feeding was set to high, the pump pressure was set 26.5 - 27.5 kpa, the flow was 2.0 l/min (standard 1.0 l/min or more) when the air feeding was set to medium, the pump pressure was set 21.6 - 22.6 kpa, the flow was 1.8 l (standard 0.68 l/min or more) when the air feeding was set to low, the pump pressure was set 19.6 ¿ 20.6 kpa, the flow was 1.2 l (standard 0.50 l/min or more).Based on the evaluation findings, the light source has a worn air joint due to normal wear, but the device passed all functional inspection.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2429304 - 2022 ¿ 00162.

Event Description

The customer reports after a colonoscopy procedure using an evis exera ii colonovideoscope and an evis exera ii xenon light source, overnight, the patient developed a perforation.The scope did not malfunction in any way during the procedure.No endo therapy devices were used in the procedure.To treat the bowel perforation, the patient had a surgical bowel resection and hospitalization.The patient's current condition is reported as "stable at time of last conversation." case with patient identifier: (b)(6) reports the xenon light source used in the procedure.Case with patient identifier: (b)(6) reports the colonoscope used in the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, the device passed all inspection tests.The cause of the reported issue could not be identified as further information was unavailable.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15948771
• MDR Text Key: 305144995
• Report Number: 3002808148-2022-05051
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2011
• 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
• Treatment: CF-H180AL
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG