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

Model Number	490103
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During bronchoscopy, two 21g flexision biopsy needles were used.Both needles would not separate from the catheter well while trying to obtain biopsies, and they could not be fully advanced into the target station.Device 1: (b)(4), 240630, l220017, exp: 6/30/2024.Device 2: (b)(4), 240731, l220024, exp: 7/31/2024.

• Brand Name: FLEXISION
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 16582000
• Report Number: 16582000
• Device Sequence Number: 5014981
• 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): 03/14/2023
• Report Date (Section F): 03/14/2023

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: L220017, L220024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White
• Date Report Sent to FDA: 03/14/2023