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

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) 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.

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.

• Brand Name: DA VINCI S SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC 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 Key: 7016148
• MDR Text Key: 92613063
• Report Number: 2955842-2017-00761
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS2000 A51P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1