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

Model Number CLV-S45

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was not confirmed.The output connector was broken and cannot be connected due to excessive stress to the output socket, and the power cord has fallen off due to mishandling.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event most likely occurred due to a worn-out socket.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that the will aim for xenon light source over-illuminated, light control no longer works.The event occurred during preparation for use.There was no patient harm associated with the event.The device was returned and evaluated, and it was found that the output connector is broken and cannot be connected, and the power cord has fallen off, this mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

• Brand Name: VISERA 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17549536
• MDR Text Key: 321744522
• Report Number: 3002808148-2023-08405
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170275777
• UDI-Public: 04953170275777
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062049
• 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
• Report Date: 08/15/2023

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-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2012
• 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