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	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the report, the flexision biopsy needle, 21g did not work properly during a bronchoscopy procedure.The needle had to be removed from the scope and a new one retrieved.

• 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: 15751480
• Report Number: 15751480
• Device Sequence Number: 17722414
• 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): 10/24/2022
• Report Date (Section F): 10/24/2022

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: 490103
• Device Lot Number: L210042
• 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: 11/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White
• Date Report Sent to FDA: 10/24/2022