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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

Attorneys have alleged that their clients suffered injuries associated with da vinci surgical procedures.These claims do not involve reportable deaths or malfunctions.These allegations were received by intuitive surgical, inc.(isi) between january 2, 2015 - march 31, 2015.For those claims where procedure dates are provided, the dates range from (b)(6) 2003 - (b)(6) 2014.

Manufacturer Narrative

This medwatch report reflects 99 initial events and 115 supplemental events summarized as part of exemption number e2013035.This medwatch report also includes 39 corrections for previously submitted events.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.

• Brand Name: DA VINCI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 4799958
• MDR Text Key: 16854479
• Report Number: 2955842-2015-00794
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2015
• Patient Sequence Number: 1