MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HDTV MONITOR REMOTE CABLE 8.5M

Model Number	MAJ-1995
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that when activating the flow button on the hdtv monitor remote cable 8.5m it was intermittent on the endobronchial ultrasound (ebus) tower during the diagnostic procedure.There were no reports of patient harm or impact associated with the reported event.
Additional Manufacturer Narrative
During troubleshooting with olympus technical assistance center (tac) there were no abnormalities found, it was most likely that the reported issue was due to the keyboard.The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to e2, e3 (inadvertently left off the initial report), g2 (also selected health professional), correction to d4 model number.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to a keyboard issue.Olympus will continue to monitor field performance for this device.

• Brand Name: HDTV MONITOR REMOTE CABLE 8.5M
• Common Device Name: HDTV MONITOR REMOTE CABLE
• 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: 17333430
• Report Number: 3002808148-2023-07170
• Device Sequence Number: 6647516
• Product Code: NWB
• UDI-Device Identifier: 04953170305061
• UDI-Public: 04953170305061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2023

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-1995
• Device Lot Number: 7501712
• Was Device Available for Evaluation?: No
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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