MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. XENON LAMP

Model Number	MD-631
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received and evaluated at olympus service center (b)(4).Device inspection, the following were noted during device evaluation: return equipment: lot is 15r.Visual inspection: there was no abnormality in the appearance.Actual machine confirmation: the problem was not reproduced.Operation check: there is no abnormality when connecting and operating according to the instruction manual.Based on evaluation findings, the reported issue was not able to be reproduced.Investigation is ongoing.This report will be supplemented accordingly following completion of investigation.
Event or Problem Description
It was reported that the user is using otv-s190 and clv-s190 in combination.A clv lamp lighting failure error e103 occurred when power is turned on.The user power off and turn on the device and when it starts up without any problem, an error e102 occurred.The user replaced the lamp with a spare lamp and the error disappeared.The customer stated that the subject lamp has been used for about 100 hours.The issue found at preparation for use.There is no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4 - the device was manufactured in june 2016.A final device manufacturer date is not available.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 specific root cause of the errors codes could not be determined at this time as the event was not replicated during evaluation.The following information is stated in the instructions for use: "code: e102 a84.Error message: clv lamp goes out check the check lamp.Cause: the light source device is out of order.Corrective action: immediately turn off the power of the light source device and inspect the lighting lamp according to the "instruction manual" of the light source device.If there is nothing wrong with the lighting lamp, immediately turn off the power of the light source device, unplug the power plug of the light source device from the medical outlet, disconnect the power cord from the power inlet of the light source device, and contact olympus.Code: e103 a83.Error message: clv lamp lighting failure check the check lamp.Cause: the light source device is out of order.Corrective action: immediately turn off the power of the light source device and inspect the lighting lamp according to the "instruction manual" of the light source device.If there is nothing wrong with the lighting lamp, immediately turn off the power of the light source device, unplug the power plug of the light source device from the medical outlet, disconnect the power cord from the power inlet of the light source device, and contact olympus.".Olympus will continue to monitor field performance for this device.

• Brand Name: XENON LAMP
• Common Device Name: XENON LAMP
• 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: 13546550
• Report Number: 8010047-2022-03103
• Device Sequence Number: 20147809
• Product Code: GCT
• UDI-Device Identifier: 04953170355950
• UDI-Public: 04953170355950
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: MD-631
• Device Lot Number: 15R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OTV-S190. CLV-S190.
• Patient Sex: Unknown