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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 470309
Device Problems Break (1069); Difficult to Remove (1528); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
Event Type  malfunction  
Event Description
Needle driver not working great during case. Then was not able to remove instrument from arm. No tissue stuck in grasper even with the "key" 1 life left manufacturer response for xi/x mega sutrecut needle driver, xi/x mega sutrecut needle driver (per site reporter). Intuitive has received the part associated with this complaint and completed investigations. Failure analysis investigations replicated/confirmed the customer reported complaint "was not able to remove instrument from arm" clarification, the instrument was found to have an input disk broken. Input disk 7 was found completely detached from the base of the housing. Improper cleaning during reprocessing most commonly causes this failure.
 
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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 Key9882438
MDR Text Key185051623
Report Number9882438
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 Received03/26/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470309
Device Catalogue Number470309-14
Device Lot NumberN10190617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
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 Manufacturer03/26/2020
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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