MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A60P9B

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Internal Organ Perforation (1987); Blood Loss (2597)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root causes for the alleged post-operative complications experienced by the patient. It is unknown if the gastric perforation occurred during the diagnostic laparoscopy procedure or the da vinci-assisted surgical procedure. Isi has attempted to contact the site to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report. A follow-up mdr will be submitted if additional information is received. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2013. No related system errors were found to have occurred during the da vinci surgical procedure. Each reusable (multi-use) instrument used during the da vinci surgical procedure has been used in subsequent surgical procedures without any reported issues. This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient was found to have sustained a gastric perforation, developed an unspecified embolism, and experienced a gi bleed. However, at this time, the root causes of the -postoperative complications are unknown.

Event Description

It was reported that after undergoing a da vinci-assisted ventral hernia repair procedure, the patient was found to have sustained a gastric perforation on post-operative day 1. Prior to undergoing the da vinci-assisted surgical procedure, the patient had also undergone a diagnostic laparoscopy procedure with adhesiolysis. A surgeon repaired the gastric perforation via open surgery and had to remove mesh. After going home, the patient reportedly developed an unspecified embolism and gi bleed. No further clinical information was provided.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6547806
• MDR Text Key: 74584454
• Report Number: 2955842-2017-00277
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2017
• 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: 05/05/2017 Patient Sequence Number: 1