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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
Event Date 07/17/2013
Event Type  Malfunction  
Event Description

It was reported that during a da vinci s hysterectomy procedure, the surgical staff encountered an error 23017 system fault. At the time the error occurred, the surgeon was reportedly cauterizing. The surgeon claimed that she let go of the foot pedal and the master tool manipulator (mtm) moved on its own causing the instrument to burn the patient's uterus. The surgical staff was able to override the error message and the surgical procedure was completed. The initial reporter of this complaint, a nurse, indicated that there was no harm or injury to the patient since the uterus was removed.

 
Manufacturer Narrative

On july 19, 2013, an intuitive surgical inc. (isi) field service engineer (fse) performed a field evaluation at the site. The fse reviewed the system logs for the site and found the error 23017 pointing to the right mtm. 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's side console. One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr). The fse resolved the reported error 23017 issue by replacing the right mtm. The fse also indicated that the surgeon eye piece on the high resolution stereo viewer (hrsv) needed replacement for an unspecified reason. The fse replaced the surgeon eye piece. The fse tested the system and verified that the system was ready for use. The mtm was returned to isi and evaluated. During the first power up of the mtm, an error code of 23017 for axis 1 was triggered. Engineering restarted the mtm three more times and was unable to replicate the error. Engineering also sine cycled the arm for 4 hours and the mtm did not trigger any 23017 errors. Engineering also check all motor cables and connections and no issues were found. When the right mtm triggers 23017 fault the following is triggered: right mtm disengages with psm and turns off all amps and the left mtm soft locks. If energy is activated via foot pedal, activation stops; however, if the foot pedal is pressed again, energy will be activated. All psms will soft lock during a 23017 fault. Energy would have stopped immediately at the time of the 23017 fault. In the system logs there is nowhere to verify if the surgeon stepped on the pedal again to activate the energy. Isi reviewed the system logs for this site with this error 23017 and the system worked as intended during the fault. The right mtm turning the amps off correlates with the reporter's claim of the mtm moving. Any psm motion that may have occurred after the fault is not driven by the affected right mtm. If the instrument was in motion at the time of the fault, there is some possible tip motion as the arm quickly 'coasts to a stop'. At this time there is no information on how far the instrument moved in order to contact the uterus. Engineering evaluation indicated that the mtm triggered several error codes of 23 and 30 which indicated a wheel communication issue. Engineering found an intermittent and faulty connection on the motor power connector and main communication error of the main harness leading to the embedded serializer (esmb) printed circuit assembly (pca). On august 13, 2013, isi contacted the surgeon who performed the reported surgical procedure. She indicated that the surgical procedure was not recorded and the error 23017 occurred approximately half way through the hysterectomy procedure. According to surgeon, the right mtm moved on its own towards the posterior of the console while her fingers were within the velcro loops. She claimed that the mtm movement ripped the velcro loops from her fingers. She also indicated that she was cauterizing with a monopolar curved scissors (mcs) instrument installed on the right patient side manipulator (psm) and her head was within the hrsv when the right mtm moved on its own. The psm is an instrument arm located on the patient side cart (psc) that provides sterile interface for the endowrist instrument. She could not recall if the mcs instrument was colliding with another instrument or anatomy when the mtm moved on its own. When the right mtm moved, she removed her foot from the foot pedal. However, the surgeon claimed that the mcs instrument burned the patient's uterus when the mtm moved on its own. Since the right mtm moved to the back of the console and was out of reach, the surgeon indicated that she had to go below the console to re-grab the right mtm. After contacting an isi technical support engineer (tse) for assistance, the surgical staff was able to override the error 23017 message. The surgeon indicated that she was able to complete the da vinci si hysterectomy procedure with no further issues. She denied that the patient sustained any intra-operative or post-operative complications. The surgeon indicated that she has had no recurrences of the reported error message or mtm issue since the event occurred. As of the date of this report, there have been no reported reoccurrences of the reported issue by the site. Based on the information provided, this complaint is being reported due to the following conclusion: the surgeon claimed that at the time an error 23017 system fault occurred, she let go of the foot pedal and the instrument tip moved at the time of the fault to come into contact with the uterus and cause damage. However, at this time, there is no indication that the patient sustained a serious injury due to the reported issue. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.

 
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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 Key3293519
Report Number2955842-2013-03073
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 07/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIS2000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2013
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received07/17/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2010
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: 08/16/2013 Patient Sequence Number: 1
Treatment
DA VINCI S SURG SYS INST., ACCESSORIES, & ESU
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