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

Model Number	CLV-S45
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: establishment name exceeded the character limit.The full name is: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the front panel of the light source was flickering.The issue occurred, during reprocessing.There were no delay, injury or death.The patient was not under anesthesia.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.Additional information added to fields: b5, d10 (added serial number), h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was not confirmed; however, the front panel was found to be damaged and not working.Based on the results of the investigation, it it likely that the front panel failure was the cause of the inoperable front panel; however, a definitive root cause could not be established.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The intended diagnostic hysteroscopy procedure was completed using a similar device.

• Brand Name: VISERA XENON LIGHT SOURCE
• Common Device Name: XENON 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: 20086223
• Report Number: 3002808148-2024-08224
• Device Sequence Number: 7664182
• Product Code: GCT
• UDI-Device Identifier: 04953170275777
• UDI-Public: 04953170275777
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: CLV-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2012
• 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: OTV-S7; OTV-S7 SN # (B)(6)
• Patient Sex: Unknown