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

Model Number CLV-S190

Device Problems Break (1069); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Event Description

The visera elite xenon light source was returned as part of the asset return process.During routine inspection of the device by olympus, found broken output connector with interrupted power supply.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned as part of the asset return process found scope detection check, appearance check and power switch check failed.Since output socket is worn out, light guide cable cannot be securely connected.Crack, damage or deformation of parts.Due to detachment of power switch, the power supply is interrupted.Top cover peeled off.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, phenomenon (1), ¿output connector is broken and cannot be connected¿, was confirmed and it was determined to have occurred due to excessive stress applied to the output socket.The reported phenomenon (2) ¿intermittent power: faulty power supply.Because the power switch is detached, the power supply is interrupted.Power switch needs to be upgraded¿, occurred due to the broken power switch caused by the operating force applied to it and the number of times that the switch was pressed has exceeded the original assumption.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.Olympus will continue to monitor field performance for this device.

• 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: 16619511
• MDR Text Key: 312413785
• Report Number: 3002808148-2023-03020
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2013
• 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