MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number 380894-10

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 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis was able to reproduce the customer reported failure during sine cycle.The following parts will be replaced as a fix: espm pca, main wire harness and axis 1 motor.During functional testing, a 23027 error occurred.The espm board will be replaced.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable to 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 surgical procedure, the customer experienced multiple recoverable faults.The customer attempted multiple power cycles prior to calling intuitive surgical, inc.For technical support assistance.The isi technical support engineer (tse) had the customer do a hard cycle on the system and perform an emergency power off (epo) of the patient side cart (psc).The customer tried recovering but the issue kept reoccurring.The customer stated that the endoscopic control manipulator (ecm) was the one locking up.At that time, the customer made the decision to bring in another psc from another system to complete the procedure.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and replaced the ecm to resolve the reported issue.The ecm is the camera arm located on the patient side cart (psc) which provides the sterile interface for the 3d endoscope.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 7341822
• MDR Text Key: 102584216
• Report Number: 2955842-2018-10075
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380894-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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