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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 07/06/2012
Event Type  Other  
Manufacturer Narrative

Despite multiple requests, no additional information has been received from the hospital regarding this event. Intuitive surgical investigation has shown that it is possible for the electrosurgical unit (esu) currents to pass through the instrument arms to ground, through the cannula accessory to the patient, if the patient is not properly grounded or if the grounding pad used by the surgical staff is faulty. As of (b)(4) 2012, the site has continued to use their da vinci si surgical system and there have been no reported recurrences of this issue at this hospital.

 
Event Description

It was reported that after a da vinci si pulmonary wedge resection procedure was completed, a burn was observed at one of the port sites when the cannula accessory was removed from the instrument arm. The burnt skin was excised, however, the patient was burnt all the way through the tissue.

 
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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
jane clay
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2712015
Report Number2955842-2012-00391
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberIS3000 A6.0P6
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received07/24/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2012
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: 08/23/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI INSTRUMENTS AND ACCESSORIES
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