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

Model Number CLV-190

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Olympus (ocg) was informed that the customer evis exera iii xenon light source had ¿electric flashes from the light source socket¿ which occurred during inspection of the equipment prior to procedure.The customer reported the problem occurred sporadically (about 3 times) when turning the lamp on (light source is already on) and with the endoscope connected.The electrical flares were visible at the front where the endoscope is connected and through the ventilation opening on the side of the light source.The intended procedure was completed using the same set of equipment.No death, injury was reported.

Manufacturer Narrative

The olympus field service technician visited the user facility to evaluate the referenced light source.The customer¿s reported problem was not confirmed.The light source was returned to the regional repair center for further service/inspection.Dust was observed inside the device with normal wear and tear on the scope socket connector, however, no other defects were identified.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon could not be reproduced, and a root cause could not be identified.It was noted, however, that the device will be cleaned off of dust.It was also recommended to replace the s-socket.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The clv-190 instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿[important information ¿ please read before use].Avoid using the light source in a dusty environment.This may damage the light source.¿ // [3.3 installation of equipment].Clean and vacuum dust the ventilation grills using a vacuum cleaner.Otherwise, the light source may break down and gets damaged from overheating.¿ the cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

• 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: 14645594
• MDR Text Key: 301762868
• Report Number: 8010047-2022-09752
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: 06/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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