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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
Model Number IS1200 A4.3P9
Event Date 08/12/2010
Event Type  Death  
Event Description

It was reported that post a successful da vinci hysterectomy procedure, the patient developed an infection and was not discharged as planned. Ten days post op, the patient was given a blood thinner and expired due to an arterial bleed. Reportedly, the patient's demise was unrelated to the da vinci surgical system.

 
Manufacturer Narrative

On november 30, 2010, an isi clinical sales representative spoke to the surgeon that performed the da vinci hysterectomy on the patient. The surgeon stated that the patient did have an autopsy performed which found that the patient had an injury to her left external iliac artery. The source of the injury was not confirmed. Based on the limited information provided, it is indeterminable if the da vinci system, instruments or accessories contributed to the patient's demise. As of december 3, 2010, no adverse events have been experienced with the site's system.

 
Manufacturer Narrative

On (b)(4) 2012, isi received a legal summons indicating that the patient expired on (b)(6) 2010, post op a da vinci si hysterectomy with bilateral salpingoo-oophorectomy and pelvic node dissection procedure performed on (b)(6) 2010. Emergency surgical procedures performed on the patient on (b)(6) 2010, revealed that the patient had sustained a burn to the right external iliac artery, pumping blood in the body cavity, causing bowel ischemia incompatible with life. Following the surgical procedure, pain medication was continually administered to the patient without good affect due to significant pain experienced by the patient.

 
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Brand NameDA VINCI 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 Key1915208
Report Number2955842-2010-00528
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other,Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/11/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS1200 A4.3P9
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received04/16/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2005
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: 12/06/2010 Patient Sequence Number: 1
Treatment
DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES
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