MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/27/2013

Event Type  Injury  

Manufacturer Narrative

(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 july 3, 2018 - october 2, 2018.For those claims where procedure dates are provided, the dates range from august 2013 - may 2018.

• Brand Name: DA VINCI
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8061541
• MDR Text Key: 126940239
• Report Number: 2955842-2018-10662
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• 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 Age: 56 YR