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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
Catalog Number 470347
Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)
Patient Problem Insufficient Information (4580)
Event Date 08/12/2021
Event Type  malfunction  
Event Description
When instrument was installed, lights on da vinci arm were flashing yellow. An error message was shown on the screen stating "instrument was not recognized". Instrument was removed and replaced into da vinci arm, but the same message occurred. Writer grabbed a new instrument and opened to sterile field. When installed into arm, instrument was recognized and was able to be used. Unrecognized instrument was not inserted into patient port. Instrument marked as "broken" and taken off of field.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer rd
sunnyvale CA 94086
MDR Report Key12370164
MDR Text Key268249031
Report Number12370164
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 08/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number470347
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2021
Event Location Hospital
Date Report to Manufacturer08/26/2021
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 Unkown

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