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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A6.0P6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
On (b)(6) 2013, intuitive surgical inc. (isi) contacted the isi csr who initially reported the event to obtain additional information concerning the reported event. The csr indicated that he attempted to obtain additional information regarding the reported event from the surgeon and robotics coordinator at the site; however, the surgeon and robotics coordinator declined to provide any information regarding the reported event. The csr stated that he was present for approximately 30 minutes during the surgical procedure and during that time he did not observe that any complications had occurred. The csr indicated that the site has not made any allegations that the da vinci si system, instruments, and accessories caused or contributed to the patient's demise. Isi has also made several attempts to contact the risk management department to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report. The site has declined to release any information regarding the reported event. A review of the da vinci si system logs showed no system malfunction occurred during the procedure performed on (b)(4) 2013. As of the date of this report, isi has not received any complaints of a malfunction of the da vinci si system, instruments, or accessories related to this event.
 
Event Description
It was reported that after completion of a da vinci si hysterectomy procedure performed on (b)(6) 2013, the patient expired during recovery. No other details were provided.
 
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Brand NameDA VINCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 94086
MDR Report Key3027945
MDR Text Key10590256
Report Number2955842-2013-01039
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIS3000 A6.0P6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received03/01/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/29/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
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