MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-41

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported problem was reproducible so the universal surgical manipulator (usm) 3 was replaced to resolve the reported problem.The system was tested and verified as ready for use.The unit was returned to isi for failure analysis (fa) and the reported allegation of "insertion axis of usm3 is sluggish/ resistive when the usm is fully extended" was confirmed and replicated.On the system test, the usm passed all testing without reporting any relevant faults or errors.On patient side cart (psc) fixture test platform (pftp) testing, the usm failed insertion friction speed low indicating a fault with the insertion axis.After testing, the usm was visually inspected, and it was found to have rust on the insertion rail.As a fix, the spar subassembly will be replaced.The unit passed direction tests, sensor checks, carriage lissajous, the sine cycle, carriage friction tests, brake tests, carriage strength tests, carriage switches, carriage/acm fan and fiber tests.No images or videos were shared for the event.Log review confirms the occurrence of a ventral hernia etep surgical procedure on the reported event date of (b)(6) 2022 using system (b)(4).System logs were reviewed/analyzed as part of the isi tse and isi fse's investigation.This complaint is being reported based on the following conclusion: a usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a conversion/abortion.

Event Description

It was reported that during a da vinci-assisted ventral hernia etep surgical procedure, the insertion axis on universal surgical manipulator (usm) 3 was sluggish/resistive when the usm was fully extended.The issue occurred with both an endoscope or instrument installed on the usm.The usm was taken aside and the procedure continued with arms 1, 2 and 4 and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) attempted to obtain additional information via follow-up, however, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 14962773
• MDR Text Key: 303917898
• Report Number: 2955842-2022-12864
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES