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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC. DAVINCI FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 470205
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2018
Event Type  Injury  
Event Description
Davinci fenestrated bipolar forceps would not close on one side. The instrument was removed and reseated without success of return of function. Instrument removed from field. No harm to patient. Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.
 
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Brand NameDAVINCI FENESTRATED BIPOLAR FORCEPS
Type of DeviceFENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd. building 101
sunnyvale CA 94086 5304
MDR Report Key7288816
MDR Text Key100883387
Report NumberMW5075399
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 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205
Device Lot NumberN11161219 0162, VERSION: 14
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

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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