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

Model Number	CLV-S200-IR
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed due to motor shaft failure.The motor was responsible for the movement of the lenses and it was discovered that the motor was not connected to the toothed belt.In addition, rear panel bent, air duct break, and front panel damage were observed.The probable cause of the defect was due to wear/tear damage with customer mishandling and with increasing use/time.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported the visera elite ii xenon light source display is flashing and there is no light output.The event was found during receipt inspection and there was no patient harm or 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 final investigation.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 legal manufacturer's investigation, an abnormality in the drive of the lens plus evidence of a strong external stress were found, which suggests that the phenomena may have been caused by an external force.In addition, it was determined that damage due to wear and mishandling likely contributed to the event.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿important information ¿ please read before use.Caution: do not apply excessive force to the light source and/or other instruments connected.Damage and/or malfunction can occur.¿ olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE II 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13954129
• Report Number: 8010047-2022-05371
• Device Sequence Number: 20061430
• Product Code: OWN
• UDI-Device Identifier: 04953170386138
• UDI-Public: 04953170386138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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-S200-IR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown