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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST ONE VESSEL SEALER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number 410322
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2013
Event Type  malfunction  
Event Description
During the robotic procedure, the surgeon wanted to use the vessel sealer. The tech loaded the vessel sealer into arm 1 of the patient cart of the robot. It was witnessed that the vessel sealer will burn out and cut on the first try, afterwards the surgeon tried to use it again and it was witnessed that the vessel sealer would burn only. Another device was needed. There was no harm to the patient.
 
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Brand NameENDOWRIST ONE VESSEL SEALER
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1250 kifer road
sunnyvale CA 94086
MDR Report Key3021230
MDR Text Key3262034
Report Number3021230
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 03/19/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number410322
Device Lot NumberS10121219
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2013
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/26/2013

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