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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI XI FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI XI FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number DA VINCI XI
Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2017
Event Type  Other  
Event Description
Conductor wire dislodged, cautery failure. No pt harm.
 
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Brand NameINTUITIVE SURGICAL INC.
Type of DeviceDA VINCI XI FENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer rd
sunnyvale CA 94086
MDR Report Key7104610
MDR Text Key94500264
Report NumberMW5073890
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 Pharmacist
Type of Report Initial
Report Date 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberDA VINCI XI
Device Catalogue Number470205-14
Device Lot NumberS10170117-0116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2017
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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