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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 A70P6B
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 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the device involved with this complaint and completed the device evaluation. Failure analysis was not able to reproduce the reported failure during sine cycle, but was able to confirm the reported failure via error logs. Visual inspection was performed. Sine cycle was performed without any issues. Tests performed via dte and matlab passed. 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 an error 1 message pointing to the left master tool manipulator (mtm) on surgeon's console. The customer contacted intuitive surgical, inc. (isi) technical support engineer (tfe) for assistance and asked the customer to power cycle the system and exercise the left mtm for several seconds. The system powered and homed successfully with no errors. The tfs informed the customer that error 1 could return and become non-recoverable. At that time, the surgeon made the decision to convert to another da vinci system. There was no report of patient harm, adverse outcome, or injury. An isi field service engineer (fse) was dispatched to the facility and was not able to reproduce the reported failure, but was able to view the error in the system logs. To resolve the issue, the fse replaced the mtm. The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the ssc. One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).
 
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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 Key7009958
MDR Text Key92544518
Report Number2955842-2017-00760
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 other
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P6B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
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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