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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 12/30/2009
Event Type  Injury  
Event Description

It was reported, that while mobilizing the left internal mammary artery during a da vinci s cabg procedure, the micro bipolar forceps (mbf) instrument jumped forward and punctured the patient's artery. The damaged section of the artery was transected and the healthy portion of the artery was used to complete the bypass. It was also reported that throughout the case, pneumo was established and lost several times. The isi representative present during the procedure indicated that prior to the mbf instrument jump, the surgeon noted that when the master tool manipulator was moved, the instrument felt stuck and then moved. It is believed that the surgeon caught the mbf instrument in the patient's rib. The planned surgical procedure was completed with no further issues or patient harm.

 
Manufacturer Narrative

(b) (4) - the system was evaluated by a field service engineer (fse). The fse found no error codes associated with the reported malfunction when reviewing the system error logs and was unable and to replicate the reported failure mode. Functional testing of the system revealed that the patient side manipulator (psm) on which the micro bipolar forceps instrument was installed functioned normally, however, an axis of the psm was found to be out of tolerance. Although the psm axis was found to be out of tolerance, it is highly unlikely that the failure mode in itself would have caused or contributed to the instrument jump experienced by the customer. The psm is an instrument arm located on the patient side cart that provides the sterile interface for the endowrist instruments. The affected psm was replaced to repair the system. A dvd of the recorded procedure was returned to isi for review. Engineering observed a sudden motion of the insertion axis of the psm causing the instrument to pierce the patient's artery. The distance traveled appeared to be larger than 1cm. Engineering also observed other instances where the instrument tip appeared to make sudden movements, however, they were of a smaller magnitude than the movement that caused damage to the patient's artery. Engineering concluded that the root cause of the instrument movement was due to motion being impeded by a large amount of static friction. The source of the friction is unknown. Some of the possible sources are sterile drape, a bent instrument, or a bent cannula. In this case, the surgeon would move the master tool manipulator (mtm) and the instrument would not move initially due to the friction, however, once the surgeon moved far enough for the instrument to overcome the friction, the instrument could make a quick jump to catch up with the mtm. The master tool manipulator refers to the master controller which provide the means for the surgeon to control the instrument and endoscope inside the patient. One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr). The psm was returned to isi for failure analysis investigation. Engineering was unable to replicate the customer reported failure mode, however, the axis out of tolerance issue was confirmed and it was determined that the axis potentiometer and motor/encoder had malfunctioned. As of (b) (6) there have been no reported recurrences of the issue at this hospital.

 
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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.
950 kifer rd
sunnyvale CA 9408 6
Manufacturer Contact
karen vane
950 kifer rd
sunnyvale , CA 94086
MDR Report Key1590517
Report Number2955842-2010-00031
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIS2000 A5.1P8
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2010
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received12/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2007
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: 01/29/2010 Patient Sequence Number: 1
Treatment
DA VINCI S SYST, INSTRUMENTS, ACCESSORIES & ESU
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