MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-10

Device Problem Connection Problem (2900)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

The reported issue was addressed with phone support.The isi field service engineer (fse) followed up with the customer and confirmed that the customer rebooted the system to resolve the reported issue.No site visit was conducted.The system was working properly and no additional action was required.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 the reported malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted ureterolysis surgical procedure, the customer encountered persistent ¿match instrument grip¿ message on the screen.The isi technical support engineer (tse) helped the customer pressed emergency stop button to recover the system; however the reported issue remained.The tse helped the customer restart the system and after the system restart, the customer could not control the arm 1.The customer elected to use another surgeon side console (ssc) to continue the procedure.The procedure was complete robotically with no injury to the patient.On 02/22/2019, intuitive surgical inc.(isi) followed up with the initial reporter and obtained additional information.The customer completed the procedure robotically with no injury to the patient.After the procedure, the customer replaced the fiber cable and both surgeon side consoles were working normally.On 02/27/2019, intuitive surgical inc.(isi) followed up with the technical support manager and obtained additional information.The isi technical support engineer (tse) exhausted all troubleshooting steps with the customer except the fiber cable connections.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: pat flanagan ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8407720
• MDR Text Key: 142367738
• Report Number: 2955842-2019-10180
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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