MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; WRISTED NEEDLE DRIVER

Model Number	478115-03
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 wristed needle driver instrument was analyzed and found to exhibit imprecise motion.Visual inspection found no issues at the distal end.The instrument passed the recognition and engagement tests.The instrument did not move intuitively with full range of motion in all directions.The instrument movements were imprecise (normal but non-exact within joint limits and in the expected direction with vibrations or small-scale dithering.) the complaint regarding abnormal movement was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The wristed needle driver instrument has been further evaluated by the isi failure analysis engineer (advanced failure analysis) and the initial failure analysis was confirmed.The instrument was placed on an in-house system and confirmed to exhibit unintuitive motion.It was observed that when attempting to execute the roll motion, the wrist moved intuitively but in the opposite direction of the master tool manipulator (mtm) command.When manually manipulating the roll gear, the main tube does not follow the motion.It was observed that the roll gear was broken which caused the motion failures as it is no longer connected to the main tube.An isi clinical development engineering (cde) replicated the customer reported issue.The wristed needle driver instrument was driven on a system and resulted in controlled motion in an unexpected pitch/yaw direction.Instruments also had limited range rotational motion when commanded by the user.There was no uncontrolled motion observed.The motion issues were immediately detectable when the instrument was taken into following and the effect of the failure prevented the user from being able to complete any surgical tasks.The evaluation also confirmed that at full instrument insertion, the roll output gear still resides outside of the cannula seal, which would prevent fragments from falling inside the patient during single incision procedures.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tip of the wristed needle driver instrument tip had no sufficient movement.A backup instrument of same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the wristed needle driver instrument was inspected prior to use with no abnormality.The customer confirmed that the instrument jaw movement did not match the action intended by the surgeon persistently.The issue occurred while the surgeon¿s head was inside the surgeon console (sc)¿s high resolution stereo viewer and the surgeon was attempting to manipulate instruments from the ssc.The timing of instrument movement was not appropriate.No shakiness/ friction/ external collisions was experienced/observed.There was no instrument-to-instrument or system arm-to-arm interference.The drape number was unknown, and the drape would not be returned.There was no injury to the patient as result of the event.

• Brand Name: SINGLE-SITE
• Common Device Name: WRISTED 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: 17936346
• Report Number: 2955842-2023-19199
• Device Sequence Number: 6455156
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(10)T10220920
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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: 478115-03
• Device Catalogue Number: 478115
• Device Lot Number: T10220920 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: Female