MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. XENON LAMP

Model Number	MAJ-1817
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the light in the xenon lamp went out after 100 hours while being used on the endo tower.The issue occurred after a diagnostic gastrointestinal procedure.The device was exchanged and there were no reports of delays or patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the lot number provided was invalid.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, as the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: XENON LAMP
• Common Device Name: LAMP
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19181862
• Report Number: 3002808148-2024-03865
• Device Sequence Number: 7431081
• Product Code: FET
• UDI-Device Identifier: 04953170304835
• UDI-Public: 04953170304835
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: MAJ-1817
• Device Lot Number: ZD5150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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: ENDO TOWER.
• Patient Sex: Unknown