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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470184
Device Problem Malposition of Device (2616)
Patient Problem No Information (3190)
Event Date 01/16/2018
Event Type  malfunction  
Event Description
Davinci xi permanent cautery spatula had exposed wire cauterizing tissue. Doctor noticed and immediately called to robot rep. Rep came into the operating room and examined the equipment. Repair request submitted and instrument tagged.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key7391910
MDR Text Key104176164
Report Number7391910
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470184
Device Lot NumberN10170608
Other Device ID NumberPERMANENT CAUTERY SPATULA
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2018
Event Location Hospital
Date Report to Manufacturer03/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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