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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 03/23/2012
Event Type  Injury  
Event Description

It was reported that during a da vinci si pulmonary lobectomy procedure, the patient's pulmonary artery was lacerated, requiring hemostasis of the affected vessel using a cadiere forceps instrument to allow for completion of the planned surgical procedure using open surgical techniques. After obtaining adequate exposure, the site attempted to manually open the grips on the cadiere forceps instrument using several different allen wrenches, however, the instrument grips would not release. The site then attempted to release the instrument using the master tool manipulors (mtm), however, the error message unable to align masters was observed. Unable to resolve the issue, the site contacted isi technical support engineering (tse) for troubleshooting assistance. After performing an emergency stop/recover of the system, the grips on the cadiere forceps instrument opened. No other information concerning the reported event was provided.

 
Manufacturer Narrative

On (b)(6) 2012, isi's supervisor of technical support engineering contacted the surgeon, dr. (b)(6) at (b)(6) to discuss the difficulties experienced while attempting to release the cadiere forceps instrument. Dr. (b)(6) indicated that after damage to the patient's pulmonary artery occurred, he used a cadiere forceps instrument to clamp down on the vessel to stop the blood flow to allow for conversion of the procedure to open. Dr. (b)(6) made the decision to release the cadiere forceps instrument from the patient bedside, instead of from the surgeon side cart. However when the surgical staff attempted to use an allen wrench to release the instrument, the instrument would not release. The tse reiterated that the instructions in the system user manual states that the emergency grip release mechanism facilitates removal of an instrument in the event of a system fault. Dr. Abbas was advised to perform an emergency stop in these situations to remove instruments from the patient side without a system error. Several follow up attempts with the site have been made concerning the patient's status, however, no additional information has been provided. A follow-up mdr will be submitted to the fda if additional information becomes available. As of (b)(4) 2012, there have been no reported recurrences of this issue at this hospital.

 
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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 Key2543963
Report Number2955842-2012-00177
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2012
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? Yes
Event Location Hospital
Date Manufacturer Received03/23/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2012
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/20/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES
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