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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI S ENDOWRIST SYSTEM,SURGICAL

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INTUITIVE SURGICAL, INC. DA VINCI S ENDOWRIST SYSTEM,SURGICAL Back to Search Results
Model Number 420205
Device Problems Difficult To Position (1467); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2013
Event Type  malfunction  
Event Description
During a robotic assisted hysterectomy the physician stated that the bipolar forceps was "floppy" and he could not control the movement of the forcep. The forcep instrument was removed, cleaned and re-attached to the manipulator and re-test with no success. The physician also reported that the needle driver instrument was not manipulating correctly. The manufacturer representative replaced both robotic instruments and had the system rebooted. The surgeon was able to complete the procedure without additional failures.
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manufacturer response for robotic fenestrated bipolar forceps, da vinci si surgical system (per site reporter).
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manufacturer to retrieve and evaluate.
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manufacturer response for robotic mega suturecut needle driver, da vinci s (per site reporter).
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manufacture to retrieve. What was the original intended procedure? robotic assisted hysterectomy.
 
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Brand NameDA VINCI S ENDOWRIST
Type of DeviceSYSTEM,SURGICAL
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kilfer road
bldg 101
sunnyvale CA 94086
MDR Report Key3021241
MDR Text Key3255813
Report Number3021241
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 03/22/2013
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/22/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420205
Device Lot NumberM10121016 239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2013
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2013
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer03/26/2013

Patient Treatment Data
Date Received: 03/22/2013 Patient Sequence Number: 1
Treatment
VIDEO CONSOLE.; ROBOTIC SYSTEM SURGICAL STATION, ROBOTIC SYSTEM
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