MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number 380990-13

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, customer stated that they have a non- recoverable 31030 fault.A technical service engineer (tse) reviewed logs and confirmed that surgeon side console (ssc) and patient side cart (psc) subsystems were timed out.Tse walked customer through a system hard power cycle and reseated fiber cables and system powered up error free.However, after some time, they had a message about the instrument control box (icb) powered off.There were instruments installed and a fenestrated bipolar was holding onto tissue.Tse explained that they would need to use the instrument release wrench to open the jaws of the instrument that was holding onto tissue prior to removing the instrument.It was confirmed that they were able to release the tissue and remove all instrument arms safely and undock.Tse confirmed the 32031 error.It was confirmed by the customer via follow-up email that the procedure was converted to open surgery and was completed 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 replaced the isi core controller (icc) to resolve the issue.The system was tested and verified as ready for use.Isi has received the icc for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.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.A log review confirmed the procedure date of (b)(6) 2022 on system (b)(4).Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted after the start of the procedure because the icb was powered off.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.Follow-up was attempted, but patient information either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Manufacturer Narrative

The core controller (icc) was returned for failure analysis but the reported failure could not be reproduced.However, the error/fault was confirmed via error logs/system logs.The customer reported complaint: unrecoverable fault 31030, repeated 31030 faults caused by the patient side cart (psc) and the surgeon side console (ssc) not being recognized intermittently.The core was replaced, the system stopped faulting, and carts were then recognized consistently.The core was installed and tested on the pca test system.The system started up without any error, all carts were recognized without any delay.The system ran 30x power cycles, and the auxiliary video processor (avp) board randomly logged error 310.There was no problem detected.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• 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: 14247576
• MDR Text Key: 299401904
• Report Number: 2955842-2022-11312
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110874
• UDI-Public: (01)00886874110874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-13
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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.