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

Model Number	490103-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during an ion endobronchial lung biopsy procedure, the biopsy needle was extended and broke inside the sheath.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting broke.An investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Isi has not received the biopsy needle involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode has not been determined.This complaint is reportable malfunction event due to the following conclusion: it was alleged that the biopsy needle extended and broke inside the sheath, the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 21G
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16679146
• Report Number: 2955842-2023-11757
• Device Sequence Number: 7967310
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)LNN22003
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 490103-10
• Device Catalogue Number: 490103
• Device Lot Number: LNN22003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2022
• 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: Male