MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. KEYBOARD

Model Number	MAJ-1710
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a radial endoscopic bronchial ultrasound (ebus), the lcd screen of the subject device was not working.The customer did not have any other keyboard or another (eu-me1) device to try.They already power cycled the (ei-me1) device and reseated the keyboard and got the same issue.The ebus was performed as an elective surgery for a mediastinal node biopsy.The procedure was aborted and the patient was taken off of general anesthesia.The procedure has been rescheduled for a later date but not yet completed.Aborting the procedure did not result in any harm or delayed treatment or diagnosis of a life-threatening condition for the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide correction to the initial with information inadvertently left out (g2) and to provide an update to field (h4).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 and since the subject device was not returned, a specific root cause of the reported event could not be identified with the information received.Olympus will continue to monitor field performance for this device.

• Brand Name: KEYBOARD
• Common Device Name: KEYBOARD
• 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: 19638744
• Report Number: 3002808148-2024-05936
• Device Sequence Number: 17915609
• Product Code: ITX
• UDI-Device Identifier: 04953170264955
• UDI-Public: 04953170264955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1710
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2013
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown