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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL, INC. DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Event Type  Injury  
Event Description

Attorneys have alleged that their clients suffered injuries associated with da vinci surgical procedures. These claims do not involve reportable deaths or malfunctions. These allegations were received by intuitive surgical, inc. (isi) between january 2, 2015 - march 31, 2015. For those claims where procedure dates are provided, the dates range from (b)(6) 2003 - (b)(6) 2014.

 
Manufacturer Narrative

This medwatch report reflects 99 initial events and 115 supplemental events summarized as part of exemption number (b)(4). This medwatch report also includes 39 corrections for previously submitted events. If additional information is received, follow-up reports will be submitted to the fda. (b)(4).

 
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Brand NameDA VINCI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale , CA 94086
MDR Report Key4799958
Report Number2955842-2015-00794
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 05/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Type of Device Usage Reuse

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