MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOBRONCHIAL ULTRASOUND PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number UM-S20-17S

Device Problem Material Twisted/Bent (2981)

Patient Problem Nodule (4551)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The probe kinked during a bronchoscopy.Left upper lobe nodule, right upper lobe nodule.

• Brand Name: ENDOBRONCHIAL ULTRASOUND PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 16683648
• MDR Text Key: 312863188
• Report Number: MW5116332
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Hispanic