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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS4000
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2017
Event Type  malfunction  
Manufacturer Narrative
Isi received the unit involved with this complaint and completed the device evaluation. The acp board was returned for failure analysis for error code 32100 which means that an arm frl was hit because of a hardware iv monitoring error. The board was installed in the acp3 slot of an in-house test system and it came up with no errors and all the gantry motors were driven through their full range of motion with no issues. The system was deployed for draping with no issues but when the arms were being stowed the system threw error 32100 as the gantry was being lowered. However, the error did not get logged since it was intermittent. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted hysterectomy procedure, the customer experienced repeated recoverable errors 32100 pointing to axes controller platform (acp3). The customer was able to recover the fault and continue with the procedure. However, the errors reoccurred, and the customer was unable to recover the fault. The site contacted an intuitive surgical, inc. (isi) technical support engineer (tse) for troubleshooting but the issue persisted. At that time the site decided to bring in another patient side cart (psc) from another system to complete the procedure. It was confirmed that the site completed the procedure with no further issues. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure. The fse replaced the acp3 to resolve the issue. The acp refers to the motor driver boards to drive the patient side cart (psc) and gantry motors.
 
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Brand NameDA VINCI XI 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
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7179548
MDR Text Key96970712
Report Number2955842-2018-00021
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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