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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This medwatch report reflects 3 initial events and 12 supplemental events summarized as part of exemption number (b)(4).If additional information is received, follow-up reports will be submitted to the fda.

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) 2014 - (b)(6) 2016.

• 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: 6803857
• MDR Text Key: 83029575
• Report Number: 2955842-2017-00543
• 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: 08/18/2017

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• 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