MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEO ADAPTER

Model Number	AR-TL08E
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this issue by the olympus representative, the device yielded no image.There is no harm to any patient or persons.
Additional Manufacturer Narrative
The device is returned but the device evaluation is not yet completed.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, the legal manufacturer's final investigation and customer follow-up.B5: updated with information received.The device was evaluated where no abnormalities were found though there were several technical defects such as the housing was loose, there was a missing screw on the mount unit and the locking was not working properly.Based on the results of the investigation, it is likely the proper vision of the rigid endoscope could not be obtained due to the faulty locking lever function of the scope mount, causing the device to not connect with the rigid endoscope properly and wobble.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The event was identified at the start of a ureteroscopy procedure.The procedure was completed successfully with a similar camera.

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14341800
• Report Number: 8010047-2022-07913
• Device Sequence Number: 14786545
• Product Code: GCJ
• UDI-Device Identifier: 04953170023972
• UDI-Public: 04953170023972
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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-TL08E
• Device Lot Number: 22054677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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
• Patient Sex: Unknown