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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 A5.1P8
Event Date 06/01/2011
Event Type  Injury  
Event Description

On april 16, 2012 isi received a legal summons indicating on (b)(6) 2011, the patient underwent a da vinci s hysterectomy procedure at (b)(6). During the surgical procedure the patient sustained injuries to her left ureter and bladder. The planned surgical procedure was converted to open laparotomy surgery with repair of the bladder injury. The patient was given two units of packed red blood cells due to blood loss during surgery. The patient was discharged from the hospital on (b)(6) 2011. On (b)(6) 2011, the patient began having severe pain in her back and noticed that she was passing urine through her vagina. Secondary to this, the patient went back to the hospital and had radiology tests performed which, confirmed that the patient had a ureteral injury requiring an immediate diversionary nephrostomy tube to be placed by a radiologist. A percutaneous nephrostomy tube was placed and the stent was able to pass freely into the bladder. The patient was outfitted with a nephrostomy bag to collect her urine. The patient was then taken back to the operating room and the ureteral stent in the left ureter was internalized. This allowed for the discontinuation of the nephrostomy bag. On (b)(6) 2011, the patient was taken back to the operating room for a cystoscopy, left ureteral stent removal, bilateral ureteroscopy, and right retrograde pyelogram. Despite all of this treatment, the patient had recurrent difficulty with pelvic pain and bladder function and continued to experience involuntary loss of urine through her vagina. The patient had to undergo an additional operation on (b)(6) 2011, consisting of cystoscopy and fulguration of bladder lesion for a diagnosis of vesicovaginal fistula. Despite this treatment, the patient continues to suffer from nocturea, pelvic pain, dyspareunia, and continued leakage of urine vaginally.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

A review of the site's system log found that no system error codes were generated during the surgical procedure. At this time it is indeterminable as to what caused damage to patient's ureter and bladder. Requests for additional information have been made to the hospital's risk management department and to the surgeon. To date, no additional information has been received. A follow-up medwatch report will be submitted if additional information is received.

 
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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 Key2577302
Report Number2955842-2012-00212
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS2000 A5.1P8
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received04/16/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2007
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: 05/16/2012 Patient Sequence Number: 1
Treatment
DA VINCI S INSTRUMENTS AND ACCESSORIES
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