MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-31

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, arm 2 on the patient side cart felt heavy and lagging.The customer called in to report the issue after the robotic portion of the procedure was completed.The technical support engineer (tse) confirmed there were no associated faults in the logs.The procedure was continuing as planned with no reported injury.Attempts have been made to obtain additional information from the customer concerning the reported event with no success.

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 universal surgical manipulator 2 (usm) to correct the reported issue.The system was tested and verified as ready for use.Isi has received the usm, however, failure analysis has not completed their investigation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.A review of the rfe procedure log showed two simple prostatectomy procedures were performed on (b)(6) 2022 on system (b)(4).At this time, it is unknown which procedure is applicable to this reported event.This complaint is considered a reportable event due to the following conclusion: at this time it is unknown if the customer abandoned or disabled the universal surgical manipulator (usm) after the start of the procedure.It is unknown if the surgeon was able to continue with the procedure robotically using 3 arms due to the heavy arm.The fse replaced the usm to correct the reported issue.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h3.Product evaluation information can be found in the following fields: h6 and h10.Intuitive surgical, inc.(isi) received the usm involved with this complaint and completed the device evaluation.Failure analysis confirmed and replicated the reported complaint.The unit was tested on an in house system and passed normal mode.During normal mode while performing the back drive test, stiffness and lag was felt along with the yaw and pitch axis.The unit went through testing on a psc fixture test platform and passed direction tests, lissajous, chipencoder virtual absolute (cva) characterization, sensors check, sine cycle, brake release test, brake hold test, advanced brake test, carriage strength test, friction test, carriage friction test and carriage switch test.The yaw and pitch motor modules, harmonics drives, and the elbow bearings will be replaced as a fix to the report problem.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 15525980
• MDR Text Key: 303320290
• Report Number: 2955842-2022-14324
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2022
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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 Sex: Male