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

Model Number	490103-17
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested that the biopsy needle be returned for failure analysis investigation.However, the product has not yet been received as of the date of this report.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, on the fourth pass the needle snapped.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The biopsy needle has been returned and evaluated by the failure analysis (fa) team.Fa could not confirm or reproduce the reported complaint.A visual inspection was performed on the biopsy needle.The sheath length was measured to be 924mm, within the 925mm +/- 1mm sheath length specification.No physical damage was found on the handle.No kinks were found on the sheath.The thumb screw and needle stop were fully functional.The needle fully extended and retracted during initial inspection.The biopsy needle was placed on an in-house catheter.Thumb screw was locked in place, the needle stop was set to position #3, and the needle was extended and retracted at a 15mm tip bend radius.The biopsy needle was extended and retracted successfully 14 times during testing on the in-house system.No sheath tip movement or friction was observed.No product issue was identified.

• 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: 20356816
• Report Number: 2955842-2024-20227
• Device Sequence Number: 7996187
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)CNC23A011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: CNC23A011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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: Prefer Not To Disclose