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

Model Number 380652-40

Device Problem Unintended System Motion (1430)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the clinical sales representative (csr) stated that the surgeon lost control of arm 4.Technical support confirmed that arm 4 lost intuitive motion.The site had changed instruments and reseated the adapter with no change.The site moved to arms 1, 2, and 3 only.Arm 4 was disabled, and the case continued.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The customer stated that universal surgical manipulator (usm)3 had more issues and wanted usm3 replaced.The fse could not replicate the reported issue but identify error code 22021 on usm3 and usm4.The fse replaced usm3 to resolve the issue.The fse also found errors 417 and 1154 when performing a log review.These errors pointed to the power supply of the endoscope controller (ec).This part was also replaced to resolve the errors.The system was tested and verified as ready for use.Isi has received the usm and the ec.Failure analysis (fa) has not yet been completed for the usm, but was completed on the ec.A supplemental mdr will be submitted once fa results are completed for the usm and/or if new information is received.The ec was tested and the reported failure was replicated.The unit was installed into a test system and it failed with error 41 at start-up.Power was applied to the ec at the test bench, and the right power supply was found to not be functioning and requires replacement.The root cause of this issue was found to be a component failure.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the site's system logs for the reported procedure date was conducted by a technical support engineer (tse).The investigation revealed the following possible related system error: 22021 - grip calibration failed on usm4 with inserted tool: not provided (failure reason: offset too high).Based on the information provided, this complaint is considered a reportable malfunction due to 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 procedure change.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D02: isi received the universal surgical manipulator (usm) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the reported failure (non intuitive motion with errors 22021 and 22020).The usm unit was tested on an in-house system and passed normal mode.Errors 22021 and 22020 were confirmed via the error logs/system logs.During the visual inspection, the fa technician found surface contamination on the gearboxes' degrees of freedom (dofs) five through nine.The unit went through more testing on a patient side cart (psc) fixture test platform (pftp) and passed direction tests, lissajous, chipencoder virtual absolute (cva) characterization, sine cycle, friction test, carriage friction test, brake release test, brake hold test, advanced brake test, carriage strength test, and carriage switches test.Per engineering change order (eco) c273681, the carriage will be upgraded to version -19 as a fix to the reported problem.Isi also received the endoscope controller (ec) involved with this complaint and completed the device evaluation.Failure analysis investigation replicated the reported error 417.This ec unit was installed on the test system, and it failed by triggering error 41 at start-up.For troubleshooting, the fa technician applied power to the ec at the test bench and found the right power supply was dead and needed to be replaced to correct the problem.Also, per service demand, the ec will be upgraded from version 372601-16 to -20 by replacing the light engine.

• 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: 14035752
• MDR Text Key: 298425208
• Report Number: 2955842-2022-10912
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-40
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• 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.