MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO ADAPTER

Model Number	A10-T2
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the camera head video adapter had a cloudy lens.The issue occurred during preparation for use and the unspecified diagnostic procedure was completed using a similar device.There was no delay or report of patient harm.
Additional Manufacturer Narrative
E1 facility name: (b)(6) hospital.The device was returned to olympus and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report is being supplemented based on additional information provided by the completed investigation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found flooding inside the main body and f rings and contact point corrosion.Based on the results of the investigation, the cause of the problem could not be identified.It is probable that the image did not function normally due to water immersion inside the main body and f-ring, and that "blurred lens" occurred.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.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18847137
• Report Number: 3002808148-2024-31214
• Device Sequence Number: 7757961
• Product Code: GCJ
• UDI-Device Identifier: 04953170023422
• UDI-Public: 04953170023422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955404
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: A10-T2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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: OTV-S7H-1N
• Patient Sex: Unknown