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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST MEGA SUTURECUT ND SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471309
Device Problem Failure to Cut (2587)
Patient Problem Insufficient Information (4580)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
Mega suture cut needle driver would not cut, 8 lives left on instrument.
 
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Brand NameENDOWRIST MEGA SUTURECUT ND
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key13024742
MDR Text Key282389727
Report Number13024742
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 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471309
Device Lot NumberN10201012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2021
Event Location Hospital
Date Report to Manufacturer12/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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