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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470194
Device Problems Break (1069); Material Protrusion/Extrusion (2979)
Patient Problem Insufficient Information (4580)
Event Date 11/06/2021
Event Type  malfunction  
Event Description
While the surgeon was using the mega needle driver inside the patient it had broken. There was a wire sticking out of it and broke the needle on the suture that the surgeon was using. Proper management was informed of the issue and the instrument was removed from the field and placed in a red bag for inspection. All counts were correct at the end of the procedure.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12810587
MDR Text Key280750477
Report Number12810587
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 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470194
Device Catalogue Number470194
Device Lot NumberN11210208 0010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2021
Event Location Hospital
Date Report to Manufacturer11/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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