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	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the biopsy needle involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation did not replicate nor confirm the customer reported complaint.Functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device.An additional observation not reported by the site that is not related to the customer reported complaint was also identified: the biopsy needle was found to have a broken sheath tip.A piece approximately 1.6 mm x 1.23 mm was not returned with the biopsy needle.The root cause is attributed to mishandling/misuse.Verification of the event details cannot be performed because no system logs were available.No image or video was available for review.This complaint is reportable malfunction event as per the following: it was alleged that when the customer was deploying the tip of the biopsy needle, it was not coming out right.Fa acknowledges that a fragment was missing from a portion of 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.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, when the customer was deploying the tip of the biopsy needle, it was not coming out right.The diagnostic procedure was completed with no reported injury.The flexion biopsy needle is used with the ion endoluminal system to biopsy tissue from a target area in the lung.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the biopsy needle instrument involved with this complaint and completed the advance device evaluation.Advance failure analysis (afa) investigation found the sheath tip to have torn off of the needle sheath.The piece was not returned with the unit.The needle assembly was disassembled.Needle sheath and needle shaft were observed to be kinked at the end of the connector body.The root cause of kink is attributed to the mishandling/misuse.The needle shaft was removed from the sheath.An unknown white, translucent residue was observed on the needle tip.Material was able to be removed by wiping it with gloved fingertips.The root cause of substance is not determinable.No damage was observed to the connector body or the thumbscrew.
Event or Problem Description
Refer to h10/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
• 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: 15567677
• Report Number: 2955842-2022-14499
• Device Sequence Number: 6076958
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)L210049
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: L210049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• 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