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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 410322
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 03/05/2018
Event Type  malfunction  
Event Description
Recoverable fault for vessel sealer. It had been working properly and then the blade would not retract back. Fault #32001. Called support line and talked to manufacturer's representative.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key7530041
MDR Text Key108783263
Report Number7530041
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 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model Number410322
Device Catalogue Number410322
Device Lot NumberM11180103
Other Device ID Number410322-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/21/2018 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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