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

Model Number 380652-41

Device Problem Power Problem (3010)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted gynecological surgical procedure, the patient side cart (psc) was running on battery.Prior to calling to speak with a technical service engineer (tse), the customer attempted to plug the system into 3 different outlets however the issue was not resolved.The breaker would not remain in the on position.The tse recommended the customer to switch to the other psc.However, the surgeon stated they would continue the procedure on battery.The tse indicated that the back up battery was not designed for completing the procedure and might not have sufficient operational time.Therefore, the 2nd psc was brought into the room and connected to the same outlets.The 2nd psc breaker did not trip, and the procedure was completed with no reported injury using the second psc.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 issue.When trying to apply power to the system and flipping the breaker to the "on" position, it immediately flipped back to the "off" position, indicating a short in the circuit.The fse found that the medical grade power supplies (mgps) were causing the short.Both mgps, the system power manager (spm), circuit breaker, and power cable were replaced.The system was then tested and verified as ready for use.Isi has received the two mgps and the spm involved with this complaint.Failure analysis (fa) is still in progress on the spm, but has been completed on the two mgps.For the first mgps, the reported failure could not be reproduced, but was confirmed via error logs and system logs.The unit was installed into a test xi system and it ran 10 power cycles without any error.Battery operation and deploy for draping function verification passed, and both fans were running.The electrical issue confirmed through the logs was found to be due to a component failure.For the second mgps, the reported failure was replicated/confirmed.The unit was installed into a test xi system but it was unable to power on.The electrical defect was found to be due to a component failure.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: system unavailability after start of a surgical procedure led the procedure to be converted.Although there was no patient injury but the converting the procedure with different system may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.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.Blank mdr fields: follow-up was attempted, but patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date and lot number for section is not applicable.Field is blank because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Field are not applicable.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Updated information can be found in fields g3, g6, h2.Additional information/product evaluation can be found in the following field: h10.D14 - on 14-jan-2022, intuitive surgical, inc.(isi) received additional information related to the reported event.Isi has received system power manager (spm) involved with this complaint.For the spm, the reported failure was not reproduced.The spm was installed onto a pca test system, where it was programmed and powered cycle 10 times.

• 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: 13202629
• MDR Text Key: 285040947
• Report Number: 2955842-2022-10028
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female