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

Model Number	MAJ-1817
Medical Device Problem Codes	Unintended Power Up (1162); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the subject device light turned on and off continuously with a crackling sound.The issue occurred during preparation for use for a diagnostic upper gastrointestinal endoscopy procedure.After restarting the machine several times, the test was performed normally.The start of the test was delayed by about 10 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: d8, d9, h3.The device was returned to olympus for evaluation and the event was confirmed.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the malfunction was caused by wear and tear of the xenon lamps.However, the root cause could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for use: "when replacing a lighting lamp, thoroughly wipe off the old heat compound from the heat sink with clean gauze.The presence of old heat compound will result in poor heat dissipation and will significantly shorten the lamp life.Avoid getting heat compound on the glass or ceramic parts of the lamp.If it gets on your skin, wipe it off with gauze.Doing so may damage the lighting lamp and cause a malfunction.Apply enough heat compound so that it does not run out.If there is too little or no coating, the lighting lamp may malfunction.Align the pins of the lighting lamp and heat sink and tighten the bolts securely.If the bolts are not tightened enough, heat dissipation will be poor, leading to equipment damage, lighting lamp failure, and the lamp life being significantly shortened.When tightening bolts, check the orientation of the washer.If the washer is oriented incorrectly, the lighting lamp may malfunction.Make sure to tighten the heat sink clamp securely.Poor heat dissipation will result in equipment damage, illumination lamps not lighting properly, and the lifespan of illumination lamps being significantly shortened.".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: 20294252
• Report Number: 3002808148-2024-09151
• Device Sequence Number: 7209268
• Product Code: FET
• UDI-Device Identifier: 04953170304835
• UDI-Public: 04953170304835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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: CLV-190 (7101848)
• Patient Sex: Unknown