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

Model Number	MD-151
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: establishment name: (b)(6).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 during the pre-use inspection, an error occurred on the video system lamp.The intended procedure was completed using a replacement lamp.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and although we could not specify the root cause of the suggested event, it is likely the defect was caused when the filament inside the lamp was checked, it was found that it was broken, and that this was causing a lamp error.It was not possible to identify the underlying cause of the filament breakage.Olympus will continue to monitor field performance for this device.

• Brand Name: HALOGEN LAMP
• Common Device Name: HALOGEN 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: 19176432
• Report Number: 3002808148-2024-03842
• Device Sequence Number: 19775614
• Product Code: FDS
• UDI-Device Identifier: 04953170064319
• UDI-Public: 04953170064319
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: MD-151
• Device Lot Number: N/A
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/16/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown