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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI

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INTUITIVE SURGICAL, INC DA VINCI Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 08/27/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4). If additional information is received, follow-up reports will be submitted to the fda.

 
Event Description

Attorneys have alleged that their clients suffered injuries associated with da vinci surgical procedures. These claims do not involved reportable deaths or malfunctions. These allegations were received by intuitive surgical, inc. (isi) between july 3, 2018 - october 2, 2018. For those claims where procedure dates are provided, the dates range from august 2013 - may 2018.

 
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Brand NameDA VINCI
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale, CA 94086
4085232100
MDR Report Key8061541
MDR Text Key126940239
Report Number2955842-2018-10662
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 Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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