MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HALOGEN LIGHT SOURCE

Model Number	CLH-SC
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light source lamp does not ignite.The issue occurred during inspection for use.There was no report of patient involvement or harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e1 and g2 (unmark health professional).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation of lamp did not ignite was confirmed.Based on the results of the investigation, the lamp did not ignite due to the failure of the thermal fuse.However, a root cause could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The intended procedure was an unspecified diagnostic procedure.

• Brand Name: HALOGEN LIGHT SOURCE
• Common Device Name: HALOGEN LIGHT SOURCE
• 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: 19779749
• Report Number: 3002808148-2024-06572
• Device Sequence Number: 18306424
• Product Code: FDS
• UDI-Device Identifier: 04953170024481
• UDI-Public: 04953170024481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: CLH-SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2019
• 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