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

Model Number 380990-02

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 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the facility and was unable to reproduce the reported complaint.Upon further troubleshooting, the fse found the illuminator master power switch had been turned off.No parts were replaced.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.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 malfunctioned were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that prior to the start of a da vinci-assisted total benign hysterectomy procedure, the illuminator would not turn on.The intuitive surgical, inc.(isi) technical support engineer (tse) instructed the customer to power off the system and cycle the breakers.The system powered back on and homed but the error persisted.The tse instructed the customer to use a third party light source to complete the procedure.There was no report of patient harm, adverse outcome, or injury.Isi made a follow up attempt and obtained the following additional information: the customer stated that port incisions were made on the patient when the issue occurred.The site completed the procedure using a third party light source.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7557366
• MDR Text Key: 109905166
• Report Number: 2955842-2018-10243
• 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: Patient
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1