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

Model Number	AR-T10E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related patient identifier: (b)(6).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the eyepiece of the pediatric scope took multiple pictures by itself without touching it.It happened when connected to the scope and monitor, laying on a sterile field.The procedure was completed utilizing the same equipment.There were no reports of patient harm.
Event or Problem Description
This report is being submitted for correction.
Event or Problem Description
It was reported that the eyepiece of the pediatric scope took multiple pictures by itself without touching it.It happened when connected to the scope and monitor, laying on a sterile field.The procedure was completed utilizing the same equipment.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.The device was returned to olympus for inspection and the reported failure was not confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: it was not confirmed that there was a problem with the device, or it was confirmed that there was no problem with the device.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.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: 19089022
• Report Number: 3002808148-2024-32131
• Device Sequence Number: 20618244
• Product Code: GCJ
• UDI-Device Identifier: 04953170023729
• UDI-Public: 04953170023729
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2024

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: AR-T10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/25/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 04/25/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/11/2024; 05/22/2024
• 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: MONITOR; OTV-S7H-1N CAMERA HEAD; SCOPE
• Patient Sex: Unknown