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

Model Number 380677-17

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the mtmr (master tool manipulator-right) and the system was tested and verified as ready for use.Mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the ssc.One mtm is assigned to the surgeons' left hand (mtml) and one to the right (mtmr).Intuitive surgical, inc.(isi) received the mtm involved with this complaint and completed the device evaluation.The customer reported complaint was reproduced during failure analysis.The root cause of the issue was found to be a component failure of the axis 1 motor and a1 motor cable.The following additional findings were identified during evaluation: the opto button pads were found to be worn out.Physical damage to the gimbal grip levers and the gimbal handle was observed.Both the inner and outer grip springs within the gimbal handle were found to be broken.The gimbal grip pads were also found to be worn out.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the site's system logs for the reported procedure date was conducted by the tse when the customer called for support.Investigation revealed error 23025 pointing to the mtmr.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopy.Although there was no patient injury reported, if the reported issue were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted ventral hernia repair surgical procedure, the system had 23025 error on master tool manipulator- right (mtmr) errors on arm 3.The intuitive surgical, inc.(isi) technical services engineer (tse) reviewed system logs which showed 23025 pointing to the mtmr, not arm 3.The procedure was converted to laparoscopy with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the system kept faulting with error 23025, therefore the surgery was converted to laparoscopy.There was no report of patient injury.The system was inspected prior to use and there were no issues with the system or the port placements.The surgical staff did not observe any outside influences that were impeding movement of the system or the patient side manipulators (psm).All troubleshooting steps were exhausted with no resolution to the issue.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11099763
• MDR Text Key: 239797698
• Report Number: 2955842-2020-11430
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-17
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1