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

Model Number IS4000 A70P6B

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 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) will not be receiving any parts for failure analysis. The isi field service engineer (fse) was not able to reproduce the reported failure and no parts were replaced. The 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 paitent harm occurred, if this malfunction were to recur it could cause or contribut to an adverse event.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, the customer experienced arm 1 and arm 3 locking up. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to press the emergency stop on the console and recover the fault and try again, however, the issue persisted. The tse had the customer reboot the system and turn off the finger clutch, but the issue was still occurring. The surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility but was not able to reproduce the reported failure.

• Brand Name: DA VINCI XI 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: 7187341
• MDR Text Key: 97752756
• Report Number: 2955842-2018-00028
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IS4000 A70P6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse