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

Model Number CLV-S190

Device Problems Insufficient Cooling (1130); Intermittent Communication Failure (4038)

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

Event Type  malfunction  

Manufacturer Narrative

The data for personal information (initial reporter) cannot be made available due to restrictions imposed by the eu general data protection regulation (gdpr, art.44-49).The device is returned and evaluated.Upon inspection, it was noted that the fan of the xenon lamp is defective with the motor not functional, so there is no more cooling of the lamp.The fan must be replaced.The connection socket partially jumps over with light guide cables and thus no longer reliably detects them.Additionally, the user complaint of dark image is not confirmed as the light output is within the specifications.The base plate and housing cover are partly heavily oxidized and must be replaced.The issues of the device may possibly be caused by wear and tear of long term usage.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The device was returned by the customer for issue of a dark image.There is no reported harm to any patient.Upon evaluation of the returned device, it was noted that the fan of the xenon lamp is defective with the motor not functional.This is preventing the cooling of the lamp.The connection socket also partially jumps over with light guide cables and thus no longer reliably detects them.This medwatch is being submitted for the reportable issues of the defective fan not cooling the device and the defective connection socket not detecting the light cables noted during evaluation.

Manufacturer Narrative

Corrected data: g2.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The root cause was not identified.However, based on the results of the investigation, it is estimated that the issue was likely caused by a failure of the fan and by a damage to the connection socket.The cause of the reported event cannot be conclusively determined.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12790695
• MDR Text Key: 283152582
• Report Number: 8010047-2021-14425
• 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: CLASS2-EXMPT
• 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
• Report Date: 12/14/2021

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
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/11/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2012
• 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