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

Model Number	430006-52
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the single port (sp) needle driver and completed investigations.Failure analysis found the primary failure of imprecise motion to be related to the customer reported complaint.The instrument was installed on an in-house system and driven.The grip tips moved in the direction commanded, however, a lag or delay in the motion was observed.Also, the instrument was found to have corrosion on the bearings.Pitch and grip input disk bearings exhibited orange discoloration.The corrosion was observed to be found on multiple components of the bearing.The instrument was found to have an excessive amount of dried, white residue on the clamping pulleys located in the backend of the instrument.The groove surfaces exhibited a residual, powder-like deposit.
Event or Problem Description
It was reported that during a da vinci-assisted sacrocolpopexy surgical procedure, the single port (sp) needle driver instrument did not move according to the surgeon direction from the console.The customer stated that they have had the issue before, and the universal surgical manipulator (usm) was changed.The instrument was switched to another usm, but the same issue occurred.The customer obtained and installed a new needle driver and the surgeon was able to continue with the surgery.The surgeon believed it was an issue with the needle driver, not the usm.There was no report of patient injury.
Additional Manufacturer Narrative
The sp needle driver instrument was transferred to engineering for the imprecise motion failure and investigations completed.The initial fa was partially confirmed, and the bearing corrosion and residues were confirmed.The instrument was placed on an in-house system, and it was found that the instrument had unintuitive motion as opposed to the imprecise movement observed in the initial fa.Specifically, it was observed that the grip tips did not follow the motions of the mtm, and when keeping the grip tips stationary and only moving in the roll direction, the entire end of the instrument would rotate unexpectedly.The instrument's housing was removed to inspect the internals of the instrument, and it was found that the instrument's roll input disk was broken.The breakage of the plastic shaft portion of the input disc for the roll direction contributed to the input disc being able to be out of sync of the instrument's main tube's rotation and led to the unintuitive motion.Since the shaft portion of the input disk was broken, the internal metal shaft could freely rotate independently of the plastic overmold portion of the input disc subassembly.It is possible that the roll input shaft and input disk were not as far out of sync during the initial fa compared to advanced failure analysis (afa), which could explain why the unintuitive motion was not initially observed.
Event or Problem Description
Refer to h10/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
• 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: 19149912
• Report Number: 2955842-2024-13714
• Device Sequence Number: 20783713
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)S10191024
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 430006-52
• Device Catalogue Number: 430006
• Device Lot Number: S10191024 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/20/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown