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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 Date 08/05/2011
Event Type  Death  
Event Description

It was reported that after a da vinci si bilateral salpingo-oophorectomy (bso) was completed, the patient returned to the hospital the next day or two days post procedure complaining of pain. A general surgeon saw the patient and made the decision to open the patient for exploratory surgery which resulted in a diagnosis of sepsis. It is unknown how the patient was treated. The patient expired on (b)(6) 2011. Since receiving this initial report, the site has been contacted to request additional information without success.

 
Manufacturer Narrative

The site's risk management department was contacted to obtain additional information related to this event and risk management advised that isi product did not cause or contribute to this event and that the no additional information would be provided included any medical records or copies of an autopsy report. A follow-up medwatch report will be submitted if additional information is received.

 
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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
nicky espinosa
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2241885
Report Number2955842-2011-00291
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2011
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? No
Event Location Hospital
Date Manufacturer Received08/09/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2010
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: 09/09/2011 Patient Sequence Number: 1
Treatment
DA VINCI SI SURGICAL SYSTEM INSTS. & ACCS., ESU
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