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

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This medwatch report reflects 3 initial events, 7 supplemental events, and 1 correction event summarized as part of exemption number (b)(4).If additional information is received, follow-up reports will be submitted to the fda.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

Attorneys have alleged that their clients suffered injuries associated with da vinci surgical procedures.These claims do not involved reportable deaths or malfunctions.These allegations were received by intuitive surgical, inc.(isi) between (b)(6) 2017.For those claims where procedure dates are provided, the dates range from (b)(6) 2011 - (b)(6) 2015.

• Brand Name: DA VINCI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale 94086 ; 4085232420
• MDR Report Key: 6560366
• MDR Text Key: 74938387
• Report Number: 2955842-2017-00286
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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