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

Model Number	490103
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Robotic ion flexision biopsy needle 21g for bronchoscopy needle used x5 in good working condition.The needle failed to retract into the sheath on the 6th pass during the procedure.The device was withdrawn from patient.No harm.

• Brand Name: FLEXISION BIOPSY NEEDLE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 16609214
• Report Number: 16609214
• Device Sequence Number: 20022730
• 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): 03/22/2023
• Report Date (Section F): 03/22/2023

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
• Device Model Number: 490103
• Device Lot Number: L220024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 03/22/2023