MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI SI ROBOTIC ARM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number RSH 0036

Device Problem Fire (1245)

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

Event Date 03/17/2021

Event Type  malfunction  

Event Description

During surgery, crna noted a flame coming from the robot arm where the robotic instrument connects to the robotic arm.Surgery immediately stopped unit flame was put out and affected surgical instruments were removed from field.New monopolar cord and monopolar scissors were added back to the field.Flame and burn on drape was not near the patient or her skin.Skin assessed after drape was removed and no injury noted to patient.Md notified.Spoke with staff involved.(b)(6) states saw flame and notified room of fire.Davinci instrument removed from robot arm 1 by dr.(b)(6) and handed to (b)(6).(b)(6) able to blow out flame.States it was the size of a large birthday candle.Biomed notified and check valley lab generator.Intuitive notified and will send field rep tomorrow to check robot.Csp notified of complete separation in bovie cord.Bovie cord from cardinal care fusion v.Muller , item 88-9199 cord with noted number (b)(4) as well.Cardinal care fusion has not been notified of incident.I do not have a rep or contact name, these items are ordered by csp and placed on our robotic trays.Photos on file.Instruments in possession of (b)(6) at this time.Will be provided to manufacturer upon request with proper chain of custody documentation.Fda safety report id# (b)(4).

• Brand Name: DAVINCI SI ROBOTIC ARM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11562249
• MDR Text Key: 242038793
• Report Number: MW5100219
• 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: 03/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSH 0036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• 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): Other
• Patient Age: 37 YR
• Patient Weight: 112