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

Model Number 490103-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 312777170
• Report Number: 2955842-2023-11757
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)LNN22003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490103-10
• Device Catalogue Number: 490103
• Device Lot Number: LNN22003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ION ENDOLUMINAL SYSTEM
• Patient Sex: Male