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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 10/19/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the customer reported failure. The unit was installed and tested in the printed circuit assembly (pca) test system. The unit failed with error 1100. Fa applied power to the unit at the test bench and found that power supply was dead and needs to be replaced to resolve the issue. 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 adrenalectomy procedure, the customer experienced a recoverable fault that would not recover. The intuitive surgical, inc. (isi) clinical sales representative (csr) contacted the isi technical support engineer (tse) multiple times for troubleshooting assistance. The system would power back on and homed successfully with no errors, however, would continue to have issues with the power. After the third call back, the surgeon decided to convert and complete the procedure using traditional laparoscopic techniques due to the system shutting down multiple times during the procedure. 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. To resolve the issue, the fse replaced the core power tray assembly.
 
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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 Key7020874
MDR Text Key92648533
Report Number2955842-2017-00763
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 company representative
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 Received11/10/2017
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 Manufacturer10/27/2017
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 Manufactured04/01/2016
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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