MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI ROBOTIC SURGICAL SYSTEM; SYSTEM, SURGICAL, COMPUTER CONTROLLED

Model Number IS3000

Device Problems Inadequate or Insufficient Training (1643); Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 05/02/2019

Event Type  Injury  

Event Description

Patient was scheduled for an elective robotic assisted resection of a pelvic mass.During the course of a robotic assisted surgery the covidien bipolar tissue fusion force triad (electro surgical unit (esu)) did discharge energy without warning causing an internal burn to the patient.An after event review of the equipment was conducted by a multi-disciplinary team and discovered that the esu has an automatic mode (indicated by the letter "a" on the program screen).When the robot is docked to the patient, the "a" indicator letter is touched on the screen and the surgeon engages/activities the robot at the controls the esu will automatically fire.The staff and the company representative were not aware of the function "a".Staff was never trained as to the dangers of the "a" automatic mode.There is no safety warning or program lock out of the "a" when activated.Fda safety report id # (b)(4).

• Brand Name: DAVINCI ROBOTIC SURGICAL SYSTEM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 8654313
• MDR Text Key: 146645834
• Report Number: MW5086974
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 69