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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. VESSEL SEALER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number M10161101
Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)
Patient Problem No Information (3190)
Event Date 05/24/2018
Event Type  malfunction  
Event Description
Vessel sealer blade was stuck and would not retract causing a recoverable fault on the robot. Second vessel sealer with different lot number was opened and had the same malfunction. A third vessel sealer with the same lot number as the first was opened and functioned without issue.
 
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Brand NameVESSEL SEALER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
building 101
sunnyvale CA 94086 5304
MDR Report Key7769149
MDR Text Key116798945
Report NumberMW5078988
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 Risk Manager
Type of Report Initial
Report Date 08/01/2018
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Lot NumberM10161101
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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