MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA XENON LIGHT SOURCE

Model Number	CLV-S40
Medical Device Problem Codes	No Device Output (1435); Defective Device (2588); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was received and evaluated at olympus (b)(6) site.The power board, transformer, xenon lamp and emergency lamp noted to be replaced.Based on the event reported and device evaluation, the reported issue was attributed to component electrical failure.The failures could be due to use handling and or maintenance issue.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that the device does not turn on, the xenon lamp and the emergency lamp does not work.The power input card and transformer are altered by a third party.The issue found during an unknown event.No patient involvement reported, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the investigation, as a presumed cause, it is highly probable that the replacement parts have deteriorated and the indicated phenomenon has occurred due to more than 15 years have passed since the product was manufactured.Olympus will continue to monitor complaints for this device.

• Brand Name: VISERA XENON LIGHT SOURCE
• Common Device Name: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12018039
• Report Number: 8010047-2021-07663
• Device Sequence Number: 17000573
• Product Code: GCT
• UDI-Device Identifier: 04953170155017
• UDI-Public: 04953170155017
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: CLV-S40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1