MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; NEEDLE DRIVER

Model Number	420117-04
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the needle driver instrument's body was damaged; it was peeling and exposed the metallic part of the clamp.The procedure was completed with no reported injury by reseating the same instrument.Intuitive surgical, inc.(isi) has performed follow-up to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
The needle driver instrument has been returned and evaluated by the failure analysis (fa) team.Fa investigations confirmed the customer reported complaint.Fa found the primary failure of insulation damage to be related to the customer reported complaint.Visual inspection was performed and the instrument was found to have insulation damage.As a result, the part of the metal main tube was exposed, and a piece of the insulation was not returned, measuring approximately 0.114" x 0.165" in size.The root cause of this failure is attributed to mishandling / misuse.A review of an image provided by the customer is consistent with the peeling and exposed metallic part of the clamp.A review of the instrument log for the needle driver instrument (pn# 420117-04 sn# (b)(4)) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 1 hour 10 minutes.The alleged event occurred on the 8th use of the instrument.This complaint is being reported based on the following conclusion: failure analysis identified 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.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: NEEDLE DRIVER
• 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: 14710337
• Report Number: 2955842-2022-12177
• Device Sequence Number: 11306697
• Product Code: NAY
• UDI-Device Identifier: 00886874111369
• UDI-Public: (01)00886874111369(10)S10130115
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 420117-04
• Device Catalogue Number: 420117
• Device Lot Number: S10130115 116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown