MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Communication or Transmission Problem (2896); Installation-Related Problem (2965)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

A customer reported to olympus, the evis exera iii xenon light source image would go in and out when wiggling the scope.The event occurred during preparation for use.There was no report of patient harm.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were identified: b30 (scope communication) error was displayed, and illumination had excessive thermal paste.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed due to a damaged scope socket.When the connected scope was slightly moved or bumped, the image is lost and a b30 (scope communication) error was displayed.In addition to evaluation in b5, the front panel was chipped.The lamp¿s life had over 500 hours.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the damaged/faulty scope socket could not be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information was provided regarding this event.The intended procedures were diagnostic esophagogastroduodenoscopy (egd) and colonoscopy.The procedures were delayed by less than 5 minutes and did not require additional treatment.The procedures were completed using the subject device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 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: 17097794
• MDR Text Key: 317744598
• Report Number: 3002808148-2023-05775
• 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: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

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: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 07/07/2023
• Supplement Dates FDA Received: 06/20/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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