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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL INC. DAVINCI ROBOTICS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number SUREFORM 60
Device Problems Difficult to Remove (1528); Failure to Form Staple (2579); Physical Resistance/Sticking (4012)
Patient Problem Tissue Damage (2104)
Event Date 03/03/2020
Event Type  Injury  
Event Description
Staples and jaw of stapler hooked onto bronchus. Staples had to be removed manually and the stapler pulled back with some resistance to be removed from the pt. Some sharp, incomplete staples had to be removed as well. (ref (b)(4)). Prior to the 7th time to use the davini xi sureform 45, the system reused to recognize the stapler. (ref (b)(4)). Fda safety report ids# (b)(4).
 
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Brand NameDAVINCI ROBOTICS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
sunnyvale CA 94086
MDR Report Key9920556
MDR Text Key186542753
Report NumberMW5094025
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/01/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberSUREFORM 60
Device Catalogue Number480460
Device Lot NumberL90191230
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/02/2020 Patient Sequence Number: 1
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