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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER Back to Search Results
Model Number 470006
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2019
Event Type  malfunction  
Event Description
While the surgeon was using the davinci needle driver during a robotic repair of an incarcerated incisional hernia, the tip of the needle driver broke off. The instrument was pulled out, examined, and it was intact. A new needle driver was used and the case was completed. There was no harm to the patient.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM, SURGICAL, COMPUTER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1090 kifer road
sunnyvale CA 94086
MDR Report Key8539268
MDR Text Key142746775
Report Number8539268
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 04/16/2019,04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470006
Device Catalogue Number470006
Device Lot NumberN10190128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2019
Event Location No Information
Date Report to Manufacturer04/23/2019
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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