MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported that the radial probe was not working.The issue occurred during super d navigational bronchoscopy procedure.It failed when the radial probe was introduced into the scope.The patient was under anesthesia and physician used alternative procedure.The procedure was completed with regular endobronchial ultrasound.Additional information received that the patient had a solitary lung mass in right lower lobe with malignant neoplasm of salivary gland.Oncology requested for additional tissue samples prior to staging.The patient was sent home in stable condition and was rescheduled later in april for navigational bronchoscopy.There were no reports of patient injury.

Event Description

This report is being supplemented to provide a correction to b2 and the registration site number.The correct registration site number for us importer is 2429304 and not the manufacturer number it was submitted under.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• 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: 19131083
• MDR Text Key: 340448021
• Report Number: 3002808148-2024-32257
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2024
• Distributor Facility Aware Date: 03/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: SCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG