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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A60.P9B
Device Problems Failure to Power Up (1476); Defective Component (2292); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2017
Event Type  malfunction  
Manufacturer Narrative
The mgps was returned for failure analysis and the reported failure was reproduced. The unit was installed on an in-house pca system and failed to power on because there was no 48v output. 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 da vinci-assisted surgical procedure, with dual surgeon side consoles (ssc) one of the sscs had no power. The customer tried multiple outlets in the operating room and cycled the breaker on the back of the ssc but the issue persisted. The surgeon made the decision to complete the planned surgical procedure using the one ssc. There was no report of any patient harm, adverse outcome or injury due to the power issue. An intuitive surgical inc. (isi) field service engineer (fse) was dispatched to the facility and found that the reported power issue was associated with the medical grade power supply. The mgps converts the ac power from the wall outlet (through the power cord) and converts it to dc power for use on the system. The issue was resolved by replacing the affected mgps.
 
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Brand NameDA VINCI SI 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 Key7126847
MDR Text Key95618628
Report Number2955842-2017-00851
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60.P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2009
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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