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

Model Number	MD-631
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the preparation for use, md-631 xenon lamp used for the clv-s40pro had a large drop in light intensity after a usage time of about 200 hours.When inside of the lamp was checked, it was black.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
The subject device was returned to omsc for evaluation.The evaluation is in progress currently.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation and correction to g2.G2 - checked "other" and added the country canada.Checked "foreign".H4 - manufactured in november 2006.The device was evaluated and confirmed the customer's report.It was also noted a crack was found on the device.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 light intensity issue likely occurred from a lamp failure.The specific root cause of could not be determined at this time.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: 13222683
• Report Number: 8010047-2022-01216
• Device Sequence Number: 4726516
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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
• Date Returned to Manufacturer: 01/06/2022
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 05/04/2022
• 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
• Patient Sex: Unknown