MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-23

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted radical hysterectomy surgical procedure, a repeated non-recoverable fault, an error 23 was displayed.The caller stated that after they hard cycled the system a recoverable and then another non-recoverable error was received.Intuitive surgical, inc.(isi) technical support engineer (tse) confirmed that the customer had error 23.The isi tse advised the caller that the error 23 was pointing to a fiber-related issue.The caller stated that they powered down and then reseated all the fiber cables and were in the process of powering back on.The system powered back up without error and isi tse heard ¿da vinci is ready¿.The site continued with the procedure.The customer called back and informed the isi tse that the error had returned.The caller removed the surgeon side console (ssc) and swap to a backup ssc.Onsite logs showed error 307 on ssc1 master tool manipulators (mtm).The procedure was completed with no reported injury.Isi followed up with the robotics coordinator and obtained the following additional information: they used another ssc to complete the case.The customer was not aware of any relevant tests performed.

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 complaint was confirmed based on the field evaluation.Isi fse switched the right master tool manipulators (mtm) to the left and installed a new mtm on the right to resolve errors 40421 and 23.The system was tested and verified as ready for use.Isi received the mtm involved with this complaint and completed the device evaluation.Failure analysis investigation reproduced the reported "error 23" via (b)(4).The embedded sterilizer in master base (esmb) printed circuit assembly (pca) and main wire harness will be replaced to resolve the issue.A review of the site's complaint history does not reveal any related complaints involving this event.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support.Investigation confirmed the reported errors.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a conversion.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.Follow-up was attempted, but the patient information was 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.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 13081685
• MDR Text Key: 284806003
• Report Number: 2955842-2021-11800
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 135