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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI SMALL GRAPTOR-GRASPING RETRACTOR SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL INC. DA VINCI XI SMALL GRAPTOR-GRASPING RETRACTOR SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number DA VINCI XI
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/30/2017
Event Type  malfunction  
Event Description
Pulley cable broke off robotic instrument during right lobectomy and needed to be retrieved from chest using intra-operative fluoroscopic imaging. Patient was exposed to additional surgical time as well as an additional incision site. Patient was exposed to extended anesthesia time due to additional medical imaging needed to locate and retrieve metal cable piece. Cable piece was retrieved and patient with no permanent harm. Intuitive surgical inc. Failure analysis report 09/2017. "failure analysis investigations found broken - distal on the following location instrument pitch cables. ".
 
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Brand NameDA VINCI XI SMALL GRAPTOR-GRASPING RETRACTOR
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
950 kifer rd.
sunnyvale CA 94086
MDR Report Key6979176
MDR Text Key90411701
Report NumberMW5072956
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 Other Health Care Professional
Type of Report Initial
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA VINCI XI
Device Catalogue Number470318-08
Device Lot NumberS10161221-0017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2016
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

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