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

Model Number 380677-13

Device Problem Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Blood Loss (2597)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

The root cause of the reported intra-operative bleeding cannot be determined. A follow-up mdr will be submitted if any additional information is received. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2018. Logs revealed no errors that point to a system malfunction. Engineering reviewed all of the events where the surgeon went "head out", and verified that any usm that was in following was forced out of following at the time of head out. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient experienced bleeding. The surgeon reportedly converted the da vinci-assisted surgical procedure to open surgery in order to control the bleeding. However, at this time, the root cause of the bleeding is unknown. There is no allegation by the site or the surgeon that an isi device caused or contributed to the reported intra-operative bleeding or that an isi device malfunctioned.

Event Description

It was reported that towards the end of a da vinci-assisted coronary artery bypass grafting surgical procedure, it was alleged that one of the arms "jumped" and punctured the right ventricle. As a result, the patient experienced bleeding and the surgeon had to convert the procedure to a traditional open surgical procedure to control the bleeding. On (b)(6) 2018, intuitive surgical, inc. (isi) received additional information from an or nurse. The nurse stated that the microbipolar forceps instrument that was installed in the left arm allegedly punctured the right ventricle. However, she did state that the surgeon actually did not see any movement; he moved his head out of the surgeon console and noticed blood welling up in the field. Hence, they cannot give any description of the alleged movement of the arm inside the patient. As a result, the procedure was converted to a traditional open procedure with an additional sternotomy incision. A stab wound was noticed in the right ventricle that was allegedly caused by the tip of the microbipolar forceps instrument. The injury on the right ventricle was repaired by placing sutures on it. The estimated blood loss was 300ml, and cell saver blood was administered. There is no video recording of the procedure. An isi field service engineer (fse) was dispatched to the site and performed a system verification and no issues were found.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7602944
• MDR Text Key: 111111411
• Report Number: 2955842-2018-10288
• Device Sequence Number: 1
• Product Code: NAY
• 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: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380677-13
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/14/2018 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES