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

Model Number 380652-40

Device Problem No Device Output (1435)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted thymectomy surgical procedure, the surgeon could not take control of the cadiere forceps instrument on arm 1.Technical support was contacted and the technical service engineer (tse) was informed by the customer that they removed the instruments and undocked.The tse viewed live logs and did not note any associated errors on arm 1.The customer redocked and moved the cadiere forceps to arm 2 and stated that it was working without issues.The customer stated that the surgeon was being prompted to match grips and noted a cone shaped pointer.Tse informed caller that there may have been an issue with the instrument assignment if the surgeon was seeing a cone shaped pointer.The tse informed the customer that the console that does not have the instrument assigned is given a pointer to help with proctoring, so that they can point at structures.The customer was continuing with the procedure which was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained additional information on (b)(6) 2022.It was confirmed that the customer moved the instrument to another arm and the surgeon completed the case with three arms.

Manufacturer Narrative

A field service engineer (fse) confirmed the customer rebooted the system to resolve the reported issue.No site visit was conducted.The system was working properly and no additional action was required.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 review of the system logs was performed.Per the review, the following was confirmed: system serial - sk1665, event date - 3/28/22.And procedure name - thymectomy.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: a universal surgeon manipulator (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.Blank mdr fields: follow-up was attempted, but patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• 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: 14231615
• MDR Text Key: 299373929
• Report Number: 2955842-2022-11277
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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