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

Model Number CLV-190

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the evis exera iii xenon light source always switches to emergency mode.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted that due to poor contact with the output socket, the scope detection function did not work.This report is to capture the reportable malfunction of scope detection not working noted at estimation.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the allegation was not confirmed.Additional issues were identified during the device evaluation: a 3rd party lamp was installed; the pump loses pressure quickly; due to damage on the power switch, the switch was stuck and could not be turned off; due to damage on the pump, the airflow was too weak.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 final 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 10 years since the subject device was manufactured.Based on the results of the investigation, the light source switching to the emergency lighting was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.A probable cause was that it was on because a third-party lamp was used.Based on the results of the investigation, it is likely the scope not being detected occurred due to poor contact of the output socket.However, a definitive root cause could not be determined.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: 16486401
• MDR Text Key: 311481249
• Report Number: 3002808148-2023-02131
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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: 02/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2012
• 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