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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A51P8
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 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received both the board and the cable related to this complaint for failure analysis. Investigation results are as follows: failure analysis was not able to reproduce the customer reported failure on the board. The board was installed on a test system and passed 20 power cycles while sitting in idle for 4 hourse without issues. Failure analysis was able to confirm the customer reported failure on the cable. The cable was installed on a test system and it failed at power up and an error message was displayed. The reported system error 23 was confirmed in the system logs reflecting that a communication error occurred. The failure analysis investigation confirmed that the cable failed to communicate when installed on a test system. 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
Intuitive surgical, inc. (isi) has not received the hard drive or cable for failure analysis. Therefore, the root cause of the customer reported failure mode cannot be determined. If additional information is received, a follow-up mdr will be submitted. 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 customer experienced errors while making the incisions on the patient. The customer rebooted the system several times but the issue remained. A technical support engineer (tse) guided the customer through troubleshooting, however, the error persisted. The customer converted and completed the procedure using traditional laparoscopic techniques due to the errors. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) made multiple follow up attempts to obtain additional information from the customer concerning the reported event with no success. 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 hard drive and cable.
 
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Brand NameDA VINCI S 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 Key7016148
MDR Text Key256505325
Report Number2955842-2017-00761
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS2000 A51P8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2008
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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