MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number A70P6B

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

An isi fse was dispatched to the facility and was unable to reproduce the reported failure.The fse tested the system and no issue were found.No part replacement was needed; therefore, no parts will be returned to isi for failure analysis.A follow-up mdr report will be submitted if additional information is received.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 surgical procedure, about an hour into the procedure after a stapler instrument was installed, all arms stopped responding.The site tried to swap and reseated the instrument and there was still no movement.The intuitive surgical inc.(isi) technical support engineer (tse) advised the customer to push the emergency stop, perform a fault override, and do a power cycle but the issue persisted.The tse suggested to the customer to power off the system again, disconnect one of the consoles, and to power back on with just one console.The system started to respond and the site was able to continue with just one console.There was no report of patient harm, adverse outcome or injury.The isi field service engineer (fse) was dispatched to the facility and was not able to reproduce the reported failure.The system was inspected, tested and verified as ready for use.

• Brand Name: DA VINCI XI SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7252753
• MDR Text Key: 99903294
• Report Number: 2955842-2018-00088
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70P6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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