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 Date 05/10/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during preparation for use, the evis exera iii xenon light source guide cable was stuck in the device, causing the unit to no longer be switched on.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation; therefore, the device evaluation could not be completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional information d8.This supplemental report is being submitted to provide a device evaluation.The device was evaluated by olympus.The evaluation found that the allegation was confirmed.The output connector was broken and could not be connected due to the light guide cable being stuck.The ring of the light guide cable got stuck on the connection socket and the unit could no longer be turned on.Additional issues were identified during the device evaluation: corrosion was present at the socket and also damaged by the light guide cable; rust was on the front panel; rust had formed on the base plate; the front panel was broken; residues were in the air hose; and the xenon lamp was from a third-party supplier.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Corrected data: d8 (¿yes¿ was selected in error on the previous follow-up report), d9 (¿yes¿ was selected in error on the initial result and inadvertently omitted from the previous follow-up report.Also, the ¿returned to manufacturer¿ field was unselected, and the return date was inadvertently omitted from the previous follow-up report), h3 (inadvertently omitted from the previous follow-up report), h4 (inadvertently omitted from the previous follow-up report), and h6 (type of investigation code ¿10¿ was inadvertently omitted from the previous follow-up report).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 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the damaged/broken output connector could not be identified.The event can be detected/prevented by following the instructions for use which state: [important information ¿ please read before use].Do not apply excessive force to the light source and./or other instruments connected.Otherwise, damage and/or malfunction can occur.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: 17078493
• MDR Text Key: 317491854
• Report Number: 3002808148-2023-05686
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 06/29/2023
• Supplement Dates FDA Received: 06/20/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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