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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DAVINCI SI ROBOTIC ARM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
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).
 
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Brand NameDAVINCI SI ROBOTIC ARM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key11562249
MDR Text Key242038793
Report NumberMW5100219
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRSH 0036
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/24/2021 Patient Sequence Number: 1
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