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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 A70P7B
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc (isi) has received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the reported failure. The unit sometimes would have no video; main board defect. The main board has been replaced.
 
Manufacturer Narrative
The hrsv has not been returned to isi for evaluation therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the part is returned (post engineering evaluation) or if additional information is received. 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 surgical procedure, the surgeon side console (ssc) high resolution stereo viewer (hrsv) right vision was lost at the start of the procedure. A technical field specialist was dispatched to the facility and determined the hrsv required replacement after troubleshooting. The surgeon made the decision to convert the procedure to traditional open techniques. No patient harm, adverse outcome or injury was reported. The hrsv was replaced to resolve the issue. The hrsv provides the video image for the ssc.
 
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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 Key7177589
MDR Text Key158782487
Report Number2955842-2018-00018
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P7B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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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