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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 07/02/2012
Event Type  Other  
Event Description

It was reported that approximately 3. 5 hours into a da vinci si pancreatectomy procedure, the site experienced multiple instances of non-recoverable system error code 23 and the surgeon was unable to control the patient side manipulator (psm) arms. Unable to resolve the issue, and prior to contacting isi technical support for trouble-shooting assistance, the surgeon made the decision to complete the planned surgical procedure using open surgical techniques. With the assistance of the tse, the site reseated the blue fiber cable, however, the fiber cable led illuminated red. The patient experienced some bleeding, however, the surgeon was unable to control the patient's bleeding due to the system issue.

 
Manufacturer Narrative

The investigation conducted by field service engineering (fse) was unable to replicate the customer reported issue. However, review of the site's system log by the fse found an occurrence of system error code 23 and it was determined that the system error code 23 was related to the blue fiber cable. The blue fiber cable carries communication over optical fibers between the patient side cart to the surgeon side console. As a precaution, the fse replaced the blue fiber cable. The system alarm (system generated fault code) functioned as designed and there was no injury to the patient. System error code 23 is reported by software to denote communication faults between two system components. In the event of these communication issues, the system records the fault and transitions to a safe state. On july 13, 2012 isi contacted the initial reporter and he indicated that he was not in the operating room when the reported issue occurred, however, he was called into the operating room to provide trouble-shooting assistance. The initial reporter indicated that he does not know what caused the bleeding experienced by the patient and that he was unable to provide any other details concerning the reported event. If additional information is received concerning the patient, a follow-up mdr will be submitted to the fda. As of july 20, 2012, there have been no reported recurrences of the 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 Key2663924
Report Number2955842-2012-00341
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 07/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2012
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? Yes
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received07/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/20/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES, & ESU
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