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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 470006
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  malfunction  
Event Description
Became stuck in arm during the case and had to be pried out with a clamp and wheel fell off back of instrument when removed. Manufacturer response for large needle drive, large needle driver (per site reporter). No credit was given.
 
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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 Key9897217
MDR Text Key186306241
Report Number9897217
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 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470006
Device Lot NumberN10190610(0070)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2020
Event Location Hospital
Date Report to Manufacturer03/30/2020
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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