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

Model Number A70P6B IS4000

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation. The failure analysis was unable to confirm the customer reported failure. The ec was installed on the test system and it came up with no errors and good video on both eyes with no anomalies. The image was in 3d and looked normal, not magnified. The system ran 10 power cycles with this ec with no errors and no video issues. 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 hysterectomy surgical procedure, it was observed that the image was very magnified and out of 3d. The site power cycled the system but the issue persisted. The site also tried two 0 degree endoscopes and one 30 degree endoscope with no change. The zoom was set to 1x, haptic zoom was off and working distance was normal. The site pressed the restore factory settings with no change. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that although the right eye was out and the vision was very magnified, the surgeon was able to complete the procedure as is. An isi field service engineer (fse) was dispatched to the facility and replaced the endoscope controller (ec) to resolve the issue. The ec contains a high-intensity light source to illuminate the surgical site and the electronics for processing the video images from the endoscope.

• 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: 6899977
• MDR Text Key: 87875630
• Report Number: 2955842-2017-00635
• 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: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: A70P6B IS4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse