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

Model Number IS3000 A60P9B

Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. During the video test there was right image loss. The issue was caused by the right camera control unit (ccu). 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 total benign hysterectomy procedure, there was vision loss in the right eye. The intuitive surgical, inc. (isi) technical support engineer (tse) advised the customer to ensure the cable connections were tight and perform a system restart with breaker reset; however, the issue persisted. The tse reviewed the logs and found an error 48232 pointing to the dual camera controller unit (doco). The tse had the customer remove the camera cable from the doco, power system up and install a new camera cable. The error 48232 recurred. The surgeon made the decision to convert and complete the procedure as a traditional open surgical procedure. There was no patient harm, adverse outcome or injury reported. An isi field service engineer (fse) was dispatched to the facility and replaced the doco to resolve the issue. The doco is located on the vsc and it receives and processes video signals.

• 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: 6861529
• MDR Text Key: 86133616
• Report Number: 2955842-2017-00595
• 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: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/13/2017
• 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: 09/05/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse