MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number 380990-11

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 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the illuminator for evaluation by internal failure analysis.The root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.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 prostatectomy procedure, the customer encountered an error when turning on the illuminator lamp.The customer contacted intuitive surgical, inc.(isi) technical support for troubleshooting assistance but the issue persisted.The customer completed the procedure with an external light source.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the site and was able reproduce the reported failure.A review of the system logs also verified the error had occurred.To resolve the issue, the fse replaced the illuminator.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the illuminator involved with this complaint and completed investigation.Failure analysis investigation was able to confirm the reported failure.Visual inspection found the unit still in good condition.However, when the unit was installed into an in-house test system, there was no power at start up.The reported errors were replicated.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7370975
• MDR Text Key: 103809821
• Report Number: 2955842-2018-10100
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES