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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 A60P9B
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 12/08/2017
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. Upon start-up, the unit failed. Fa found the fan was dusty during visual inspection. 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 malfunctioned 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 customer encountered a non-recoverable fault. The customer performed a power cycle and the surgeon side console (ssc) had no power. The intuitive surgical, inc (isi) technical support engineer (tse) instructed the customer to cycle the breakers several times on the back of the ssc and to use another wall outlet but there were no lights lit on the ssc and the customer could not hear the fans. At that time, the surgeon made the decision to covert the procedure to traditional laparoscopic. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc (isi) made a follow up attempt and obtained the following additional information: the procedure was converted to traditional laparoscopic techniques when the ssc went down. However, the site brought in another ssc from another system and completed the procedure robotically. 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 ssc power supply.
 
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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 Key7152710
MDR Text Key96211638
Report Number2955842-2017-00880
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 other
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2010
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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