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

Model Number 380677-23

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, an intuitive surgical, inc.(isi) technical support engineer (tse) was contacted for assistance.The camera pedal on the surgeon side cart (ssc) had fallen off.The customer put it back on by hand during the surgery, but it was not staying in place.It was also reported that the holding pin from the pedal was out as well.The surgery was going to be completed under these circumstances.The customer had also to move the camera manually.The procedure was completed as planned with no patient harm.Isi followed up with the initials reporter and obtained the following additional information: the system was checked before use.The malfunction occurred during the procedure.The surgery was completed with the same ssc with a delay of around 15 minutes.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the footrest due to the pedal not mounting and the pins were found to be loose.The system was tested and verified as ready for use.The complaint regarding defective camera foot pedal was confirmed based on the field evaluation, which indicates that the device did contribute to the customer reported issue.The footrest unit has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.This complaint is being reported based on the following conclusion: the customer had the camera pedal of the surgeon side cart defective after the start of the procedure, it fell off and as a consequence the camera was moved manually and not via the da vinci system.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received a da vinci product involved with this complaint to perform failure analysis.During visual inspection, the cover for the camera pedal fell off the footrest.The probable root cause is attributed to a defective foot pedal.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16076116
• MDR Text Key: 308479231
• Report Number: 2955842-2022-16210
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 106 KG