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	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Flexision biopsy needle 21g, during bronchoscopy, had a failed sheath and needle on 3 separate needles.Needles: #240930; lnn22002; exp 09/30/2024; #240930; lnn22003; exp 09/30/2024 and #241031; lnn 22003; exp 10/31/2024.

• 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: 17009862
• Report Number: 17009862
• Device Sequence Number: 7566168
• 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): 05/19/2023
• Report Date (Section F): 05/19/2023

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: LNN22002, LNN22003, LNN22003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White
• Date Report Sent to FDA: 05/19/2023