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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL ENDOWRIST ONE VESSEL SEALER DAVINCI VESSEL SEALER

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INTUITIVE SURGICAL ENDOWRIST ONE VESSEL SEALER DAVINCI VESSEL SEALER Back to Search Results
Model Number 410322
Device Problem Failure to Calibrate (2440)
Patient Problem No Information (3190)
Event Date 11/16/2017
Event Type  malfunction  
Event Description
Intuitive davinci endowrist one vessel sealer would not calibrate in davinci arm. Vessel sealer removed and replaced with a new one.
 
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Brand NameENDOWRIST ONE VESSEL SEALER
Type of DeviceDAVINCI VESSEL SEALER
Manufacturer (Section D)
INTUITIVE SURGICAL
sunnyvale CA 94086
MDR Report Key7049059
MDR Text Key92837160
Report NumberMW5073466
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number410322
Device Catalogue Number410322
Device Lot NumberM12170706
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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