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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 Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2017
Event Type  malfunction  
Manufacturer Narrative
Isi received the device involved with this complaint and completed the device evaluation. Failure analysis investigation was able to reproduce the customer reported failure mode. The black and white ffc's will be replaced a fix. 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 prostatectomy procedure, the customer was unable to move the camera arm and the system generated errors 23017, 25550, 25521. The intuitive surgical, inc. (isi) technical support engineer (tse) attempted troubleshooting and determined that the issue was the left master tool manipulator (mtml). The tse recommended the site to disable the mtml and then power cycle the system; the issue was resolved. However, the customer called back to give details on the system logs, during that time the system faulted again. At that time, the surgeon made the decision to convert the procedure post anesthesia and port placement 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 able to reproduce the reported failure. The fse replaced the mtml. 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 Key7006841
MDR Text Key92170295
Report Number2955842-2017-00754
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 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2017
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 Manufacturer10/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
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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