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

Model Number CLV-190

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the xenon light source had the scope communication error (b30 error) and the scope communication error code (e216 error) occur during preparation for use for a diagnostic procedure.The customer reported the machine repeats the error intermittently on other scopes after clearing the error.The customer reported they sent the scopes in for inspection and repair and have not had the issues reoccur after retraining the scope washers in the procedure.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.   new information added on fields: h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the errors were caused by an issue with reprocessing method of the scope.However, a definitive root cause could not be determined as a physical device evaluation could not be performed.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): 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: 18963681
• MDR Text Key: 338771942
• Report Number: 3002808148-2024-02785
• 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
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2012
• 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