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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 Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2017
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. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
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 vanci-assisted partial nephrectomy procedure, the customer experienced a loss of light in the left eye of the surgeon side console (ssc). The site attempted to perform a power cycle, however, there was no change. The intuitive surgical, inc. (isi) technical support engineer (tse) had the site power cycle a second time and cycle the ssc breaker, however, the issue persisted. The surgeon completed the procedure with his face outside of the high resolution stereo viewer (hrsv) in the ssc due to the hrsv being black. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure. The fse replaced the hrsv left side monitor. 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 Key6652197
MDR Text Key209339089
Report Number2955842-2017-00375
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2017
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 Manufacturer06/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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