MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-13

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the component involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The power supply was installed into a test system and it failed at power up.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 likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy procedure, the customer received a ¿surgeon console not connected¿ message.The customer checked the breaker and the power to the outlet and both were correct.The technical support engineer (tse) had customer cycle the breaker and no lights came up on the console.The surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.There was no patient harm, adverse outcome or injury reported.An isi field service engineer (fse) was dispatched to the facility and replaced the console power supply to resolve the issue.The power supply is a hardware component that supplies the surgeon side console (ssc) with power.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• 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: 7422138
• MDR Text Key: 105524747
• Report Number: 2955842-2018-10132
• 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
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1