MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASOUND CABLE

Model Number	MAJ-2056
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic ion robotic bronchoscopy with endobronchial ultrasound with cone beam, (bronchoscopy with biopsy/ flexible bronchoscopy), the sleeve around the ultrasound cable, was worn off completely and the wiring was visible (poor appearance).The procedure was completed with another similar device and procedure delayed by 45 minutes and so was patient¿s anesthesia.There was no adverse impact to the patient.

• Brand Name: ULTRASOUND CABLE
• Common Device Name: ULTRASOUND CABLE
• 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: 19656403
• Report Number: 2429304-2024-0000307
• Device Sequence Number: 15208059
• Product Code: IYN
• UDI-Device Identifier: 04953170355677
• UDI-Public: 04953170355677
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024
• Report Date (Section F): 03/12/2024

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-2056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2024
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• 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