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

Model Number	430006-52
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, the needle driver instrument experienced unintuitive motion which resulted in patient injury.The instrument moved in the opposite direction than intended.This motion caused the needle driver instrument to cause an injury to an artery on the pelvic sidewall.A clip was applied to the artery to stop the bleeding and repair the defect.The needle driver instrument was replaced with a backup needle driver instrument.This event resulted in a 20-minute surgical delay.The patient is recovering well.The procedure was completed robotically.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received a product for failure analysis evaluation.A review of the site's system logs for the reported procedure revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of unintuitive motion to be related to the customer reported complaint.The instrument was installed on an in-house system and driven.The instrument exhibited unintuitive motion.The motion exhibited by the instrument was precise, and proportional to what was commanded by the master tool manipulators (mtm), however the grip tips moved in the opposite direction.This behavior was observed in the pitch and yaw direction and presented on 3 out of 3 installs, indicating a misalignment of the coordinate frames during the engagement sequence.
Additional Manufacturer Narrative
An advanced engineering investigation was completed to determine the cause of this reported event.Initial failure analysis (fa) was confirmed, the instrument exhibited unintuitive motion when placed on an in-house system.The grip tips moved in the opposite directions as commanded by the master tool manipulator (mtm.) the instrument's housing was removed to inspect the instrument's internals, and it was found that the instrument's roll input was cracked.There were no pieces missing.With the roll input disk on the proximal end of the instrument held with one hand, the instrument's main tube was able to be rolled while keeping the input disk stationary.This indicates that the metal portion of the roll input is able to move independently from the plastic portion, which can potentially allow for the components to become out of sync and potentially lead to motion issues as the instrument may be actuated in a way that differs from what the system expects with respect to the patient side cart (psc)'s drives.Additionally, the instrument's grip input was also found cracked as well.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: NEEDLE DRIVER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 21730270
• Report Number: 2955842-2025-11817
• Device Sequence Number: 17170957
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)S10210527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 430006-52
• Device Catalogue Number: 430006
• Device Lot Number: S10210527 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/22/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male