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

Model Number 380990-03

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 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the illuminator associated with this complaint and completed its investigation.Failure analysis confirmed the reported issue.The illuminator was installed into printed circuit assembly system and started up with no errors, but the lamp failed to power on due to error code 48244.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 patient harm occurred, if the reported malfunction were to recur, it could cause or it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the illuminator lamp module would not turn on and the system faulted with repeated error code 48244; lamp ignition failure.The intuitive surgical inc.(isi) technical support engineer (tse) verified the repeated 48244/48245 faults in the system logs.The tse had the customer attempt to power cycle the system and verify the camera cable was fully seated at the vision tower and camera head.After troubleshooting, the reported issue persisted and at that time the customer decided to use a third party light source to complete the procedure robotically.There was no report of patient harm, adverse outcome or injury.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 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

Further failure analysis found that the lamp would not ignite and the power supply had also failed and would be replaced as a fix.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7639716
• MDR Text Key: 112865446
• Report Number: 2955842-2018-10320
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES