MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA PRO VIDEO SYSTEM CENTER

Model Number OTV-S7PRO

Device Problems No Display/Image (1183); Smoking (1585)

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

Event Date 09/03/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the visera pro video system center and visera pro xenon light source generated smoke just prior to the end of the examination, and it was further noted that there was no output with the video rhino laryngoscope.The issue was found during the examination and was completed using the same set of equipment.There was no delay in treatment and there were no reports of patient harm.Related patient identifier: (b)(6).Visera pro xenon light source for additional device reported for same event (b)(3).

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The investigation noted that no abnormalities could be identified in any of the areas visible.However, when the scope and the clv-s40pro device, ((b)(6).The related record) were connected to each other, it was noted that no smoke was generated, but that it was a blackout without being output.Further, when changed to equipment because of concern, the images appeared, so we confirmed that the otv-s7pro device was abnormal.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 11 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to a faulty power supply unit.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA PRO VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• 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: 17858270
• MDR Text Key: 324918779
• Report Number: 3002808148-2023-10659
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170228896
• UDI-Public: 04953170228896
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• 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: 10/11/2023

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: OTV-S7PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2012
• 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
• Treatment: CLV-S40PRO LIGHT SOURCE SN (B)(6).; ENF-V2 VISERA RHINO-LARYNGO VIDEOSCOPE SN UNKNOWN.