MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported the xenon light source had an output connector that was broken and could not be connected.It is unknown when the issue occurred.There were no reports of patient harm.

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: b3, b5, d4, d10 and e1 additional information added to field h3 and h6.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.The customer's allegation of damaged connector and couldn't be removed was confirmed.Based on the results of the investigation, the root cause could not be identified.However, it is likely that the event occurred due to the foreign object stuck in the insertion opening.Olympus will continue to monitor field performance for this device.

Event Description

The issue occurred during preparation for use for an endoscopy procedure.

• Brand Name: VISERA ELITE 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: 18966702
• MDR Text Key: 339052258
• Report Number: 3002808148-2024-02806
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: ENF-V2 (RHINO-LARGYNGO VIDEOSCOPE) S/N (B)(6); ENF-V2 - VISERA RHINO-LARYNGO VIDEOSCOPE