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

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.

• Brand Name: DA VINCI SI 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: 7152710
• MDR Text Key: 96211638
• Report Number: 2955842-2017-00880
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse