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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
Event Type  Death  
Manufacturer Narrative

Additional information received from the account indicates the patient death was the result of a heart attack and was not related to the surgery in this event. No further information provided.

 
Manufacturer Narrative

Isi has made multiple attempts to contact the physician (initial reporter) at (b)(6), for additional information concerning the reported event, however, no additional information has been provided. If additional information is received a follow-up mdr will be sent to the fda. At this time, there has been no report by the site that during the planned surgical procedure that a malfunction of the da vinci si system, instruments and/or accessories occurred.

 
Event Description

It was reported that during a da vinci si bilateral salpingo-oophorectomy procedure, during placement of the uterine manipulator, the patient's bowel was ruptured. The surgeon repaired the patient's bowel, which took approximately 3 hours to repair. Two days post op the patient experienced cardiovascular complications and complications and expired. The surgeon is attributing the patient's demise to a t-berg. No other information was 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.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
jane clay
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2539834
Report Number2955842-2012-00168
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS3000 A6.0P6
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received04/19/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2010
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: 04/18/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM, INSTRUMENT AND ACCESSORIES
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