MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FLEXISION BIOPSY NEEDLE, 21G; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	490103
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Eight devices: ion 21g tbna needle failed to deploy during the bronchoscopy case.The needle used during robotic bronchoscopy would not deploy from the sheath.The second needle was opened and used.Ion 21g biopsy needle deployed thru the side of the sheath.Rep pulled products from the shelf for return to the manufacturer.Two separate lot numbers: l220015 (3 devices) and l220017 (5 devices).

• Brand Name: FLEXISION BIOPSY NEEDLE, 21G
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale; CA 94086
• MDR Report Key: 16276977
• Report Number: 16276977
• Device Sequence Number: 12423501
• Product Code: EOQ
• UDI-Device Identifier: 00886874115961
• UDI-Public: 00886874115961
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2023
• Report Date (Section F): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 490103
• Device Lot Number: L220015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/24/2023