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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 ENDOWRIST 45 STAPLER

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INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC. DA VINCI XI ENDOWRIST 45 STAPLER Back to Search Results
Model Number DA VINCI XI
Device Problems Failure to Calibrate (2440); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2018
Event Type  malfunction  
Event Description
Stapler failed to calibrate after new staple reload was installed and stapler was re-inserted in robot arm. Once stapler was removed after failure to calibrate, stapler jaws would not open to release the new staple reload. Stapler was tested after procedure and was completed without success.
 
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Brand NameINTUITIVE SURGICAL INC.
Type of DeviceDA VINCI XI ENDOWRIST 45 STAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer rd.
sunnyvale CA 94086
MDR Report Key7214939
MDR Text Key98234286
Report NumberMW5074768
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 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI XI
Device Catalogue Number470298-11
Device Lot NumberT10171012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
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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