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

Model Number 380652-49

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Pericarditis (4448)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted for a procedure on (b)(6) 2021 on system (b)(4).While there were logged events, there were no observed events in the system logs that would suggest a related product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.All reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against any of the instruments.An isi clinical development engineer (cde) conducted clinical review and stated that any surgery performed, regardless of method, presents risk of complications and , any specific risks associated with their procedure would be discussed with their physician prior to the procedure.In terms of heart valve repair procedures, potential complications could include the following: bleeding during or after treatment or damage to the blood vessels.Blood clots that can cause heart attack, stroke, or lung problems.Infection at the incision site.Infection in the new valve (endocarditis), which is more common with valve replacement.Pneumonia.Breathing problems.Arrhythmias (abnormal heart rhythms) or the need for a permanent pacemaker.Valve failure, also more common with replacement.Bad reaction to anesthetics.The symptoms of breathing issues, rapid heartbeat, and pericarditis leading to pleural effusion are all within the risks listed above.The patient underwent a da vinci-assisted surgical procedure and experienced post-operative complications.Additionally, the patient returned to the hospital twice for medication adjustment and treatment.However, although there is no allegation that malfunction of a da vinci system, instrument, or accessory occurred, the following are unknown: the cause and severity of the post-operative complications, and the reasons why the patient required medication treatment/adjustments.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.

Event Description

It was initially reported that after a da vinci-assisted mitral valve repair procedure, the patient has a persistent cough, pleural effusion and his surgeon wants nothing to do with him.It was reported that prior to the procedure, the patient walked five miles per day, at a quick pace, and was generally in good health but post-procedure, the patient cant walk 3/4 mile without getting dizzy and lightheaded.On 03-mar-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: a da vinci mitral valve repair procedure was completed on (b)(6) 2021 on an undisclosed da vinci system.The patent presented with post-procedure symptoms of a persistent cough and pleural effusion.It was reported that the patient went back to the hospital on (b)(6) 2021 with symptoms of a rapid heartbeat and that the patient was treated with medication adjustment and the patient returned home.On (b)(6) 2021, the patient returned to the hospital again for a rapid heartbeat.The patient received a thoracentesis that allegedly revealed pericarditis that was reported as being drained.Additional information was not disclosed.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11573514
• MDR Text Key: 260729964
• Report Number: 2955842-2021-10313
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-49
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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