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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST ONE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 410322
Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2017
Event Type  malfunction  
Event Description
While using a davinci vessel sealer, an error occured. The blade on the vessel sealer would not retract. An error code followed and the sealer was taken out of patient. Manufacturer response for davinci vessel sealer, endowrist vessel sealer (per site reporter).
 
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Brand NameENDOWRIST ONE
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale CA 94086
MDR Report Key6356043
MDR Text Key68232713
Report Number6356043
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 01/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model Number410322
Device Catalogue Number410322
Device Lot NumberM10161128
Other Device ID Number8 MM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2017
Event Location Hospital
Date Report to Manufacturer01/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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