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

Model Number	MD-631
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.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.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the upper endoscopy, the endoscopic image was dark and the examination was interrupted.It had been dark since the clv-260nbi lamp (md-631) was replaced in early december, but this time it was judged that it was too dark to observe, and the procedure was put off at a later date.It was said that there was a problem with the lamp that was replaced last time because it improved after switching to another lamp in the facility inventory.It was said that the lamp became so dark that the tissue could not be identified after using it for about 10 hours after replacement.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could be duplicated.Not lit because it was out of order.There was a trace that the inside seemed to be short-circuited.The manufacturing record could not be reviewed since the serial number was unknown.It was probable that the reported phenomenon was due to a lamp failure, but the exact cause could not be conclusively determined.No more information can be provided at this time.If additional information is received, this report will be supplemented.

• 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: 13234821
• Report Number: 8010047-2022-01302
• Device Sequence Number: 14523168
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 12/28/2021
• 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: 12/18/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/03/2022
• 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