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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST STAPLER 45 DAVINCI XI

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INTUITIVE SURGICAL, INC. ENDOWRIST STAPLER 45 DAVINCI XI Back to Search Results
Model Number 470298
Device Problems Mechanical Problem (1384); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2018
Event Type  malfunction  
Event Description
Endowrist stapler was placed on robotic arm. Stapler would not register/complete calibration. Stapler removed from robotic arm. Upon inspection, it was noted by the surgical team that stapler would not open. 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 NameENDOWRIST STAPLER 45 DAVINCI XI
Type of DeviceSTAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd.
building 101
sunnyvale CA 94086 5304
MDR Report Key7352182
MDR Text Key103005041
Report NumberMW5075962
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 03/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470298
Device Lot NumberT10171109-0026
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

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