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

Model Number	MD-631
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the customers allegation was not confirmed.It was noted that the device had was cracked and could not be operated as it was broken.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to olympus that the xenon lamp had an e102 error when the device was activated.It was noted that a popping sound occurred and the emergency light turned on.The procedure was an otolaryngology endoscopy and was completed using the emergency lights.The lamp was replaced this year.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
Added d section, concomitant medical products.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause could not be determined.However, it is likely that the event was caused by abnormalities such as fracture of the ceramic part, discoloration, and shrinkage in the interior of the xenon lamp.Regarding the error e102, the following description was confirmed from the instruction manual of otv-s190: "code:e102 a84: error message: please check clv lamp turning off and illumination lamp cause: the light source device is faulty." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.

• Brand Name: XENON LAMP
• Common Device Name: XENON 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: 16043135
• Report Number: 3002808148-2022-05558
• Device Sequence Number: 12371424
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 12/27/2022; 01/13/2023; 02/20/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 12/27/2022; 02/10/2023; 03/21/2023
• 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: CLV-S190.
• Patient Sex: Unknown