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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 10/11/2012
Event Type  Death  
Manufacturer Narrative

On (b)(6) 2012 an inspection of the site's system was performed by an intuitive surgical field service engineer(fse). Inspection of the site's da vinci si surgical system by the fse found no issues and that the site's system functioned within specification. The site has indicated to the intuitive surgical clinical sales representative that the site is currently performing an internal investigation into the reported incident and is unable to provide any other details concerning the incident. Several attempts have been made to verify additional details concerning the reported event; however, no additional information was provided. A follow-up mdr will be submitted if additional information is received.

 
Event Description

It was reported 2 days post a successful da vinci si myomectomy procedure, the patient expired. The intuitive surgical clinical sales representative (csr) that reported this incident indicated that on (b)(6) 2012, the surgeon who performed the surgical procedure reported to him that a tenaculum forceps instrument being used during the surgical procedure was not moving as it should. The csr indicated that he instructed the surgeon to have the instrument removed, cleaned and re-installed. The csr indicated that the site proceeded using the instrument and the planned surgical procedure was completed. No patient harm, adverse outcome or injury was reported to have occurred at the time of the surgical procedure. On (b)(6) 2012, the intuitive surgical csr was notified by the surgeon that the patient was re-admitted to the hospital on (b)(6) 2012 due to a perforated bowel and the patient expired on (b)(6) 2012. The csr indicated that the surgeon indicated the surgical procedure went fine. The surgeon indicated to the csr that a video recording of the surgical procedure is not available and that the cause of the patient's injury is unknown. Late submission of the medwatch report is due to an reporting oversight by the responsible complaint handler.

 
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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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2890369
Report Number2955842-2012-01482
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2012
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 Received10/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
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: 12/29/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
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