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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL INC. DA VINCI XI XI FENESTRATED BI POLAR FORCEPS Back to Search Results
Model Number DA VINCI XI
Device Problems Material Discolored (1170); Stretched (1601)
Patient Problem No Patient Involvement (2645)
Event Date 04/17/2018
Event Type  malfunction  
Event Description
Da vinci fenestrated bi polar forceps showing "stretched" black energy cable on the distal end of instrument before delivery to sterile field for pt use. Instrument was removed and processed for return to mfr.
 
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Brand NameDA VINCI XI
Type of DeviceXI FENESTRATED BI POLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
oakland CA 94609
MDR Report Key7446815
MDR Text Key106250956
Report NumberMW5076603
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 Other Health Care Professional
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI XI
Device Catalogue Number470205
Device Lot NumberN10171121-0013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
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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