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 Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting the failed to advance, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The biopsy needle instrument was analyzed and the needle did not fully extend out when actuated with the needle handle at various insertion depths.The distal end did not appear to have any piercings or punctures.There was high friction between the sheath and needle shaft when trying to extend the needle using the needle handle.The complaint regarding the biopsy needle failed to advance was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.No image or video was available for review.Verification of the event details cannot be performed via system logs because system logs do not exist (ion systems do not have onsite connectivity at this time).This complaint is reportable malfunction and adverse event due to the following conclusion: it was alleged that the biopsy needle failed to advance and a fragment fell inside the patient during a da vinci assisted procedure.It is unknown if a fragment was retrieved or not.

Event Description

It was reported that during an ion endobronchial lung biopsy procedure, the biopsy needle failed to advance.The diagnostic procedure was completed with no reported injury.An intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 15921350
• MDR Text Key: 304866263
• Report Number: 2955842-2022-15744
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)L210049
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490103-10
• Device Catalogue Number: 490103
• Device Lot Number: L210049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• 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