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 (b)(4). 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. (b)(4).

• Brand Name: DA VINCI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; 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
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse