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

Model Number 380620-38

Device Problem Mechanical Jam (2983)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that prior to the start (post-anesthesia) of a da vinci-assisted radical cystectomy with other urinary diversion surgical procedure, all the input disks did not rotate after the sterile adapter was attached on arm3.An intuitive surgical, inc.(isi) technical support engineer (tse) was contacted for troubleshooting assistance.The tse verified the sterile adapter was already installed on arm3 according to the logs.The tse explained the issue could be caused by the pogo pins from the arm being stuck.The tse advised the customer to pull the pins by hand or with a tool.The customer attempted to carry out the advice, but the issue persisted.The issue was still not resolved even after a hard power cycle of the patient side cart (psc).Intuitive surgical, inc.(isi) followed up with the medical engineer and obtained the following additional information: the issue occurred prior to starting the procedure; ports were placed and anesthesia had been administered.The discs of arm3 did not rotate after draping.The issue occurred during the preparation and functionality was checked upon powering on the system.The system functionality was checked upon powering on the system.The system initially powered on without errors.The procedure was continued with three functional arms.The procedure was completed as planned with no reported injury.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse confirmed and replicated the reported failure.The fse replaced the universal surgical manipulator (usm) 3 to resolve the issue found.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the usm arm involved with this complaint and completed the device evaluation.During failure analysis, the usm was tested on an in house system and passed normal mode; however, the instruments were observed to be not engaging as the gearboxes kept spinning.This confirms the issue.After further testing it was concluded that the carriage was suspect and replacement with new rotors and gearboxes were performed.Following replacement, the usm arm was tested, operated with no further issue and was restored to specification.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No images or videos were shared for the event.A review of the site's system logs for the reported procedure date was conducted by the regulatory post market surveillance (rpms) analyst identifying the regulatory post market surveillance (rpms) analyst of the errors reported.Additional log reviews confirmed that system (b)(4) was used on (b)(6) 2022 for a radical cystectomy w/ other urinary diversion procedure.No further review is required as the logs were reviewed/analyzed as part of the isi tse and isi fse's investigation.This complaint is classified as a reportable event due to the following conclusion: a usm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.Failure analysis of the replaced usm confirmed a component failure.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.

• Brand Name: DAVINCI X
• 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: 14670795
• MDR Text Key: 302170833
• Report Number: 2955842-2022-12118
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380620-38
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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