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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 A70P5D
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
Isi has received the device involved with this complaint and completed the device evaluation. Failure analysis investigation was unable to reproduce the reported issue.
 
Manufacturer Narrative
Isi received the unit involved with this complaint, however, the failure analysis investigation is still in progress therefore the root cause of the customer reported failure has not been determined. A follow up mdr will be submitted once the failure analysis has been completed and/or 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 prostatectomy procedure, the right image on the surgeon side console (ssc) high resolution stereo viewer (hrsv) displayed static. The images displayed on the vision side cart (vsc) and external monitor were fine. The customer attempted to use a different endoscope but the issue persisted and the right monitor stopped working after power cycling. The surgeon made the decision to convert the procedure to another da vinci surgical system and the planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported. An isi technical field specialist was dispatched to the facility and was able to reproduce the reported issue. The ssc 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 Key6675291
MDR Text Key201827837
Report Number2955842-2017-00401
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P5D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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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