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

Model Number 371268-03

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 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the units involved with this complaint and completed the device evaluations.Failure analysis was able to reproduce the reported failure on the battery box.However, the reported failure could not be reproduced on the apb board.The unit was installed in a test system and ran in sine cycle for 10 minutes without issues.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, the customer was trying to drive the patient side cart (psc) to dock to patient when the system faulted with a non-recoverable fault.An intuitive surgical inc.(isi) technical support engineer (tse) reviewed the logs and noticed an 802 error.The customer tried to power down the system and perform an emergency power off of the psc but the issue persisted.At that point the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.An intuitive surgical, inc.(isi) field service engineer was dispatched to the facility to further investigate the reported issue.The fse found error 802 an replaced the battery box and the auxiliary power board (apb).The apb controls the battery system in the psc.It contains the battery charger and the battery backup control which switches main system power when ac power fails.The battery box provides backup power in the event of loss of ac power to the system.This provides enough power to safely undock from the patient.

• 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: 7448830
• MDR Text Key: 106268152
• Report Number: 2955842-2018-10153
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371268-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 04/04/2018
• 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