MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FLEXISION; BIOPSY NEEDLE, 21G

Model Number	490103-17
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the biopsy needle instrument associated with this complaint and completed investigations.The instrument was found to have a thumbscrew issue.Loosening the thumbscrew felt tight when turning it counterclockwise to fully slide the handle.Turning the thumbscrew on and off loosens and able to move the handle freely.A significant scrape mark was observed at the thumbscrew connector groove.Additionally, the instrument was found to have a broken handle.The needle handle broken off from being attached together.Slowly extending then retracting the needle and felt some tightness during the process.No missing material was observed.The biopsy needle shaft was found to have a kink.The kinked shaft was found approximately 145mm from the distal tip.A kink was also observed proximally at the base of the needled.The slight friction felt during extension and retraction potentially related to the needle being kinked.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer stated that the thumbscrew on the biopsy needle would not loosen or work during procedure.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the thumbscrew was not working and could not be controlled by the nurse.The procedure was completed with a backup instrument.
Additional Manufacturer Narrative
Additional information was received from engineering team: although manufacturing verification confirmed the gap was within specification, pressing the halves together during advanced analysis eliminated the gap.Based on the complaint, it is likely that excessive force applied while attempting to extend the needle caused the handle halves to separate.Primary failure analysis identified friction in the thumbscrew, which loosened after adjustment and allowed free handle movement.Slight friction was noted during sheath extension and retraction, and retightening the thumbscrew locked the sheath as expected.Disassembly showed no sheath damage, but the needle shaft was kinked approximately 145 mm from the distal tip, likely due to damage during use such as improper handling or aggressive jabbing.Additional analysis found a bent thumbscrew pin and multiple drag marks on the connector body, likely caused by misuse such as excessive jabbing force while the thumbscrew was locked or partially locked.The kinked needle shaft, bent thumbscrew pin, connector drag marks, and separated handle are all consistent with excessive force applied during attempted needle extension.Removal of the thumbscrew revealed scraped material and thread plating on the ratchet indicator and hub, along with white plastic debris on the hub threads.This damage was likely caused by the bent thumbscrew rubbing against the ratchet material, leading to friction during thumbscrew adjustment and sheath movement.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may include improper handling of the biopsy needle.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 21G
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 23065499
• Report Number: 2955842-2025-36521
• Device Sequence Number: 13223995
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)CNC24C100
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 490103-17
• Device Catalogue Number: 490103
• Device Lot Number: CNC24C100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ION ENDOLUMINAL SYSTEM
• Patient Sex: Unknown