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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST STAPLER 45 SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST STAPLER 45 SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470298-11
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2019
Event Type  malfunction  
Event Description
During resection of colon robotic the 45 mm intuitive robotic stapler began to malfunction. Stapler was moving uncontrollably in all directions. Operating room tech able to grab the arm and make it stop. Arm with trocar and stapler in place removed. Another stapler applied and procedure finished with no injury or adverse outcome. Stapler sent out to intuitive for evaluation.
 
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Brand NameENDOWRIST STAPLER 45
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1090 kifer road
sunnyvale CA SUNNY VALE
MDR Report Key8353316
MDR Text Key136602635
Report Number8353316
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2019,02/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470298-11
Device Lot NumberT10180109
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2019
Event Location No Information
Date Report to Manufacturer02/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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