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 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.Related patient identifiers: (b)(6) and (b)(6).

Event Description

It was reported, the xenon light source had the scope communication error (b30 error) occur during pre-use inspection.The issue occurred during a diagnostic procedure for an upper endoscopy.The procedure was completed using a similar device.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 to the following fields: h3, h4, h6.Corrected fields: d10 (correction to therapy date should be (b)(6) 2024 in the initial medwatch) e1 (added telephone number).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the presence of water drops at the time of connecting the scope may have caused a poor interface between the clv-190 and the scope, resulting in a temporary scope communication error.The event can be prevented by following the instructions for use which state: "regarding the error b30, the following items were checked in cv-190 plus's instructions for use.Coding: b30 error message: scope communication error cause: failure to communicate with the endoscope.·the following statements were checked in clv-190's instructions for use: the scope wires should be connected in a sufficiently dry condition, including the electrical contacts.If wet, the image may disappear or lead to malfunctions such as flicking." 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: 18996577
• MDR Text Key: 338914420
• Report Number: 3002808148-2024-02974
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• 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
• Treatment: CV-190 PLUS, VIDEO SYSTEM CENTER.; CV-190 PLUS, VIDEO SYSTEM CENTER.; GIF-H190 GASTROINTESTINAL VIDEOSCOPE.; GIF-H190 SERIAL NO.(B)(6).; GIF-H190N GASTROINTESTINAL VIDEOSCOPE.; GIF-H190N.