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

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

During robotic-assisted myomectomy, robotic arms stopped and froze up.The surgeon and assisted surgeons were aware.Attempted to release instrument with an emergency key without success.Davinci representative was called and consulted to restart the robot.No injury occurred robot restored to regular function without any other occurrence.Fda safety report id# (b)(4).

• Brand Name: DA VINCI ROBOT
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 10612974
• MDR Text Key: 209568381
• Report Number: MW5096981
• Device Sequence Number: 1
• Product Code: NAY
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Age: 46 YR
• Patient Weight: 68