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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 12/19/2012
Event Type  Other  
Event Description

It was reported that during a da vinci s prostatectomy procedure, the customer experienced non-recoverable system error code 212. With the assistance of an intuitive surgical, inc. (isi) technical support engineer (tse), the site removed the instrument installed on the patient side manipulator (psm) arms and powered off the system. When the site restarted the system, the issue recurred. The tse instructed the site to exercise the left master tool manipulator (mtml) on the surgeon side cart and perform a fault override; however, system error code 212 recurred. Unable to resolve the issue the surgeon made the decision to abort the planned surgical procedure. No patient harm was reported on (b)(6) 2013, isi contacted the site's or unit assistant. The or unit assistant indicated that the planned surgical procedure was completed using open surgical techniques. She indicated that she was unable to provide any other details regarding the reported event.

 
Manufacturer Narrative

The investigation conducted by the field service engineer concluded that system error code 212 experienced by the customer was associated with the left master tool manipulator (mtml) and the multiple servo driver (msd) pca board. The master tool manipulator refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon side console. One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr). The system contains five multiple servo driver (msd) pca boards, which provide drive current to the servo motors associated with each degree of freedom. The system was repaired by replacing the affected mtml and msd pca board. The system alarm (system generated fault code) functioned as designed and there was no injury to the patient. System error code 212 occurs when the actual voltage to drive current through the motors deviates from the expected voltage by a specified amount. Upon determining this condition, the safety systems put the da vinci in a non-recoverable safe state. The mtml and the msd board were returned to intuitive surgical, inc. (isi) for failure analysis investigation. Engineering confirmed the customer reported system error code 212 and found that the main cable harness and axis 3 motor were defective. The msd board output was found to be out of the acceptable range. As of (b)(6) 2013, there have been no reported recurrences of the issue at this hospital. This complaint is being reported due to the following conclusion: the surgeon made the decision to convert to open surgical techniques after encountering an recurring system error code 212 with the da vinci s surgical system.

 
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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 Key3275500
Report Number2955842-2013-02991
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 12/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2013
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 Manufacturer12/28/2012
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received12/19/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2008
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: 08/09/2013 Patient Sequence Number: 1
Treatment
DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE
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