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

Model Number CLV-190

Device Problems Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)

Patient Problems Adult Respiratory Distress Syndrome (1696); Aspiration/Inhalation (1725); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.In addition, the front panel mouth is cracked, bad scope socket-the locking mechanism is not protecting the pins, and the olympus lamp life meter read over 500 hours, lamp is expired.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon the investigation's completion or if the user facility provides any additional information.

Event Description

The customer reported to olympus that the evis exera iii xenon light source received a communication error/screen goes to black and white specks, b30 error during a therapeutic colonoscopy procedure.The patient was under (monitored anesthesia care) mac anesthesia at the time of malfunction.The procedure time was extended and completed using the same set of equipment.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional legal manufacturer's investigation findings.Since additional information was received from the customer, a re-investigation was performed by olympus.In addition to the previously submitted findings, the following was identified based on the re-investigation: it is likely that the occurrence of the b30 error resulted in the prolonged procedure.However, since the subject device was not returned for an investigation, the root cause could not be determined.

Manufacturer Narrative

Updated fields - b1, b2, b5, h1, h6.This report is being supplemented to provide additional information received from the customer as reflected on b5 and the legal manufacturer's final investigation.The root cause of the event could not be identified.Based on the following facts obtained during the survey, it is believed that the b30 error was caused by some kind of abnormality in communication with the scope due to the attachment of foreign matter or moisture at the electric junction.However, due to the fact that it has not been returned to the legal manufacturer, it was not possible to confirm the detailed status and indication phenomenon of the product, so the cause of the occurrence and root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was shipped according to specifications.The service manual confirms that a b30 error indicates a scope communication error, wherein there is registry error generation in which the hard deployment of the scope identification data fails.This is mainly generated by foreign body attachment and moisture attachment of the electric junction.(reference: cv-190 service manuals).Olympus will continue to monitor the field performance for this device.This report has also been submitted on importer medwatch report #(b)(4).

Event Description

Additional information was received from the customer.A 30-minute procedural delay was reported.The patient had a possible respiratory aspiration and was subsequently placed on a bipap machine for respiratory distress.There was no further endoscopy treatment required.

• 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: 16441044
• MDR Text Key: 310367193
• Report Number: 3002808148-2023-01793
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/15/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/25/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 04/11/2023
• Supplement Dates FDA Received: 04/05/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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
• Patient Outcome(s): Required Intervention