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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470347
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/21/2022
Event Type  malfunction  
Event Description
During case, the robotic tip up grasper broke, some metal pieces broke in patient. The doctor was in room aware, pieces collected, robin beard robotics coordinator in room and observed. Srs to be filled out and device placed in medsun. Manufacturer response for davinci tip up grasper, davinci (per site reporter) we will be notifying the manufacturer so we can arrange to have the device returned.
 
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Brand NameDAVINCI
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key14280028
MDR Text Key290669858
Report Number14280028
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 Risk Manager
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2022
Event Location Hospital
Date Report to Manufacturer05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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