MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FLEXISION BIOPSY NEEDLE, 23G; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	490102
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During bronchoscopy while attempting to obtain a needle aspiration biopsy, the device malfunctioned.After the third pass, the needle became unable to retract correctly.The device was taken out of service at that time and replaced with a new needle in order to complete the process.

• Brand Name: FLEXISION BIOPSY NEEDLE, 23G
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 15690247
• Report Number: 15690247
• Device Sequence Number: 6706811
• Product Code: EOQ
• UDI-Device Identifier: 00886874115954
• UDI-Public: 00886874115954
• 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): 10/21/2022
• Report Date (Section F): 10/21/2022

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: 490102
• Device Lot Number: L210034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 10/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Race: White
• Date Report Sent to FDA: 10/21/2022