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
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.

• 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
• MDR Report Key: 19638747
• Report Number: 2429304-2024-0000316
• Device Sequence Number: 7065120
• Product Code: ITX
• UDI-Device Identifier: 04953170264955
• UDI-Public: 04953170264955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2024
• Report Date (Section F): 05/31/2024

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?: Yes
• Distributor Facility Aware Date: 05/31/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown