MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI DA VINCI XI SURGICAL SYSTEM

Model Number IS4001-01

Device Problem Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Injury (2348)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root causes of the operative complications experienced by the patient. There is no allegation that a malfunction of the da vinci xi surgical system occurred. If additional information is received, a follow-up mdr will be submitted. The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed. Based on the available system logs, no related system errors were found to have occurred during the surgical procedure. Based on the information provided at this time, this complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, a stomach perforation, esophagus perforation, and mesh displacement were identified. However, the root causes of the operative complications are unknown.

Event Description

It was initially reported that a patient underwent a da vinci-assisted surgical procedure and the following complications were reported: stomach perforation, esophagus perforation, and mesh displacement. The patient reportedly underwent multiple surgeries and was not doing well. On 21-may-2018, intuitive surgical, inc. (isi) contacted the initial reporter, an isi clinical sales representative, who was present during the first 1. 5-2. 0 hours of the da vinci-assisted surgical procedure. The csr indicated that the patient had previously undergone a nissen fundoplication procedure via traditional laparoscopic surgery. However, the csr did not know what date the traditional laparoscopic surgery was performed, what hospital the surgery was performed, and if the patient experienced any operative complications related to the traditional laparoscopic surgical procedure. In this case, the csr indicated that the patient was undergoing a ¿re-do¿ of the nissen fundoplication procedure via robotic surgery. The csr was informed by a ¿nurse assist¿ and a ¿tech¿ from the hospital of the operative complications. However, the csr did not know the causes of the operative complications. There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

• Brand Name: DAVINCI XI
• Type of Device: DA VINCI XI SURGICAL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7557022
• MDR Text Key: 109685267
• Report Number: 2955842-2018-10241
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: IS4001-01
• 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: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 05/31/2018 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES