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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 03/26/2012
Event Type  Death  
Event Description

It was reported that during a da vinci si ovarian transposition procedure, a complication occurred and the patient started to bleed. The surgeon attempted to control bleeding by applying pressure with an instrument grasper and applying laparoscopic ligaclips. The ligaclips failed to control the bleeding and the surgeon attempted to suture the vessel, but this was also unsuccessful at controlling bleeding. The surgeon made the decision to convert to traditional open surgical techniques. The surgical staff undocked the camera arm and one of the instrument arms from the patient but kept the other two arms with the instruments in the patient. The instruments arms were applying pressure to the site of bleeding. The surgeon attempted to find the source of bleeding. It is unclear on the sequence of events after this. The patient was confirmed to have expired. It is unknown whether the patient expired during or after the procedure. No further information was provided.

 
Manufacturer Narrative

On (b)(6), 2014, intuitive surgical, inc. (b)(4) received a legal summons regarding the reported event. According to the documentation in the legal summons, on (b)(6), 2014, the patient underwent a da vinci hysterectomy procedure due to dysfunctional uterine bleeding. The pathology findings were positive for squamous cell carcinoma of the cervix. The patient was referred to a gynecological oncologist. On (b)(6), 2012, the patient underwent a positron emission tomography (pet) scan. The pet scan findings suggested that the patient had right and left external iliac and left periaortic disease secondary to increased suv intake. Following the hysterectomy procedure the patient complained of developing worsening bladder incontinence from her vagina. On (b)(6), 2012, it was discovered that the patient had developed a ureteral vaginal cuff fistula and bilateral internal ureteral stents were placed. The legal summons indicates that on (b)(6), 2012, the patient underwent a da vinci pelvic lymph node dissection and staging procedure and during the surgical procedure, the patient experienced arterial bleeding from the aorta. The legal summons indicates delayed and unsuccessful attempts were made at repairing the aorta with attempts at cpr including chest compression and cardioversion, but these were unsuccessful. The patient expired on (b)(6), 2012.

 
Manufacturer Narrative

The system was tested by a field service engineer and performed to specifications. The account stated the case complications are unrelated to the da vinci system. Multiple attempts for additional information from the account were made. To date, no further information has been received. A follow-up medwatch report will be submitted if additional information is received. As of (b)(4) 2012, no adverse events have been experienced with the site's system.

 
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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 Key2548815
Report Number2955842-2012-00182
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/26/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2012
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? Yes
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received09/24/2014
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2010
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: 04/25/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES
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