MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI ROBOT; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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

Patient Problems Pain (1994); Spinal Column Injury (2081)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Hysterectomy with da vinci robot at (b)(6) hospital for 3.75 hours.Woke with grade 4 annular tear in l5-s1 lumbar disc, causing immediate severe pain and requiring artificial disc replacement 7 months later.

• Brand Name: DA VINCI ROBOT
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC.
• MDR Report Key: 7757075
• MDR Text Key: 116408914
• Report Number: MW5078890
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 64