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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 470405
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Insufficient Information (4580)
Event Date 02/11/2021
Event Type  malfunction  
Event Description
A metal piece was sticking out of the side of the tip of a intuitive surgical, inc. Endowrist da vinci xi force bipolar (ref/catalog # 470405, ver 06, lot # n10200727 0133) after 30 minutes of use. The malfunctional xi force bipolar was replaced with another force bipolar (ref/catalog # 471405, ver 06, lot n10200914 0013). A wire was sticking out of side of second device after 1 minute of use. The second xi force bipolar was replaced with a bipolar maryland dissecting forceps.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key11384624
MDR Text Key233748908
Report Number11384624
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470405
Device Catalogue Number470405
Device Lot NumberN10200727 0133
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2021
Event Location No Information
Date Report to Manufacturer02/26/2021
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 Unkown

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