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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A51.P8
Event Date 04/18/2011
Event Type  Death  
Event Description

On april 4, 2012 intuitive surgical was contacted by the patient's grand-daughter that the patient underwent a kidney biopsy procedure using the da vinci s surgical system on (b)(6) 2011. Reportedly, during the biopsy procedure, the patient's renal artery was damaged. The planned procedure was converted to open surgical techniques to repair the affected vessel and the patient required a partial nephrectomy as a result of the damage. The patient lost 13 pints of blood. On (b)(6) 2012, the patient expired due to pneumonia, multiple organ failure and renal failure.

 
Manufacturer Narrative

On (b)(4) 2013, intuitive surgical, inc. (isi) received the patient's operative reports for the da vinci kidney surgical procedure that occurred on (b)(6) 2011 along with the operative report for the direct repair of the infrarenal abdominal aorta that occurred on the same day. The da vinci operative report, dated (b)(6) 2011, indicated that the patient underwent surgery for a left renal mass. The operative report contained the patient's background where it indicated that in (b)(6) 2010, the patient was admitted with gross hematuria. A ct scan of her abdomen and pelvis revealed a 9 mm left renal enhancing neoplasm. The patient was informed of her options and elected to proceed with the robotic laparoscopic left partial nephrectomy procedure. The operative report indicated that the da vinci surgical procedure was complicated by a tear in the right renal artery. It was noted that when the renal artery clamp was placed onto the renal artery, the renal artery injury was encountered. At this point, a decision to convert the da vinci surgery to an open surgery was made to gain better access to the renal artery and the da vinci robot was rapidly docked off the patient. The renal artery was repaired by the vascular surgeon. According to the operative report, the patient had a total blood loss of 1600 ml, which equates to 3. 4 pints of blood and not 13 pints, which was reported by the initial reporter. Based on the initial mdr that was submitted on (b)(4) 2012, the patient reportedly underwent a partial nephrectomy due to the artery injury. According to the operative reports, there was no indication that the partial nephrectomy was related to the artery injury. Patients that undergo a renal biopsy sometimes require a partial nephrectomy due to the way the blood vessels enter and exit the area of concern. In this case, the partial nephrectomy was performed likely due to the nature and location of the tumor and not due to the renal artery injury. Based on the additional information, the reported renal artery injury was observed after the renal artery clamp was placed. There were no report of any malfunction of the da vinci system and/or instruments in the operative reports. However, this complaint remains as a reportable death event since isi has not determined the root cause of the patient's death. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event. Correction: follow-up mdr 1 that was submitted on (b)(4) 2013 had serious injury selected in error. Section has been updated to death.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Several follow up attempts were made to the initial reporter to obtain the patient's medical records and a video recording of the planned surgical procedure, however, the information has not yet been provided. Should additional information be received concerning this report, a follow-up mdr will be submitted to the fda. On april 13, 2012, intuitive surgical contacted the surgeon, (b)(6) and he indicated that the intended planned procedure was a da vinci s partial nephrectomy procedure, however, he is unable to provide any other information concerning the reported event and that i should contact the hospital's risk management department. On april 20, 2012, intuitive surgical was contacted by attorney (b)(6) and she indicated that due to hippa regulations she is unable to provide additional information concerning the reported event to 3rd parties. However, the hospital will comply with any request for additional information directly from the fda.

 
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Brand NameDA VINCI S 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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2559247
Report Number2955842-2012-00197
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 04/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS2000 A51.P8
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received04/23/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2008
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: 05/03/2012 Patient Sequence Number: 1
Treatment
DA VINCI S SYSTEM, INSTRUMENTS & ACCESSORIES
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