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 Problem Nerve Damage (1979)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

The root cause of the customer alleged reported event cannot be determined.A follow-up mdr will be submitted if any additional information is received.Isi has reviewed the site's system logs for the procedure date of (b)(6) 2016.No related system errors were found to have occurred during the surgical procedure.Based on the current information provided, this complaint is being reported due to the following conclusion: after completion of a da vinci-assisted surgical procedure, it was reported the patient allegedly experienced vocal nerve damage.There was no allegation that a malfunction of a da vinci system, instrument, or accessory had occurred during the surgical procedure.However, at this time the root cause of the alleged operative complication is unknown.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

Event Description

It was reported that during a da vinci-assisted parathyroid glad surgical procedure, the patient experienced complications.The patient's spouse contacted an intuitive surgical, inc.(isi) representative and stated that his wife had nerve damage and almost lost her voice.The spouse further stated that not all the parathyroid glands were removed.On 4/4/2017, isi received additional information confirming the date of the procedure.On 4/10/2017 isi received additional information from the surgeon who stated that there were no malfunction of the isi system, instrument, or accessories.No further details have been obtained as of date of this report.

• 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: 6524317
• MDR Text Key: 73781322
• Report Number: 2955842-2017-00248
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other