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

Model Number	MD-631
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, the amount of light emitting from the device was decreased.The device was defective as light emitted was insufficient after only 300 hours of usage.The insufficient light had the potential of hindering a procedure.There are no patients impacted by this issue.
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation and device evaluation.Sections d4, d8, d9, and h6 were updated.The device was manufactured in march 2015, but the exact date is unknown.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 complaint of decreased light emission was likely due to to deterioration caused by prolonged storage of the device.However, the definitive root cause of the decreased light issue could not be determined.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: 14957646
• Report Number: 8010047-2022-11593
• Device Sequence Number: 19203786
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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: CLV-S190(S/N (B)(6).
• Patient Sex: Unknown