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

Model Number CLV-190

Device Problems No Display/Image (1183); Intermittent Communication Failure (4038)

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

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

During troubleshoot, the olympus technical support advised the customer not to hot swap scopes, to power down and remove and install scopes in the light source.The error must be cleared before attempting to an additional scope or it will appear as if the additional scope is having the same error.Also to ensure the foreign objects, such as detergent remnants, hard water residue, finger grease, dust, and lint are on the electrical contacts of scope.And to: wipe the electrical contacts on the endoscope connector using clean l int free cloths moistened with 70% ethyl or 70% isopropyl alcohol and completely dry them.After drying them, connect the endoscope to the light source.Verified/reset maj-1933 and maj-1941 (brightness, white balance & nbi) communication cables.Verified the endo scope connector on light source is clean and free of debris.Customer re-attempted scope and there are no errors present, cart operating properly at the time of call.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.

Event Description

Olympus technical support engineer was informed via service inquiry by the biomedical equipment technician at the user facility that the customer evis exera iii xenon light source has an intermittent ¿b30¿ communication error, no image defect when using 190 series type endoscope (180 type works appropriately).The reported problem was found during procedure.The procedure was completed with another similar device.No death, injury or harm was reported to olympus.

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.It has been over 4 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the b30 error could not be identified.However, it¿s likely the cause is related to dirt of liquid adhered to the electrical contacts.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: 14917978
• MDR Text Key: 303854141
• Report Number: 8010047-2022-11338
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• 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