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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST ONE VESSEL SEALER DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 410322
Device Problem Failure to Sense (1559)
Patient Problem Insufficient Information (4580)
Event Date 12/07/2020
Event Type  malfunction  
Event Description
Si robot would not recognize the endowrist one vessel sealer. Solid yellow light remained on robot arm following several attempts by staff for it to be recognized. Fda safety report id # (b)(4).
 
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Brand NameENDOWRIST ONE VESSEL SEALER DAVINCI
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
MDR Report Key10976388
MDR Text Key220915978
Report NumberMW5098279
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number410322
Device Catalogue Number410322
Device Lot NumberM10200121
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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