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

Model Number 380614-10

Device Problem Use of Device Problem (1670)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the jaws of the monopolar curved scissors did not always open/close properly.The technical support engineer (tse) viewed the system logs and did not find any error related to the problem.The site used a different instrument.The tse recommended they reseat the sterile adapter/instrument, push the emergency button and recover from the fault, and test the other arm controlled by the same master tool manipulator (mtm).The caller stated they did this and none of the actions worked.The surgeon most likely did not remove the lymph nodes due to the problem.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up on 16-feb-2022 and 21-feb-2021 obtained the following additional information: sometimes the instrument worked and sometimes it did not.The instrument was not stuck on tissue.A backup instrument was not used.The instrument was inspected prior to use and there was no damage or anything out of the ordinary.No fragment fell into the patient.The monopolar curved scissors (mcs) tip cover was present on the instrument during the procedure.The surgeon performed a limited lymphadenectomy as the surgeon did not trust the mcs for the delicate procedure step.The mcs had a problem opening/closing and did not exactly respond to the surgeon¿s movements.The patient will not be rescheduled for a lymphadenectomy at a later date according to the pathological report.The surgery was completed as planned robotically.The surgeon had the same problem with a backup instrument.

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.There were no problems during tests, but there was a lot of mechanical damage on the outside of the patient side manipulator (psm).The fse replaced the psm.The system was tested and verified as ready for use.Isi received the psm involved with this complaint and completed the device evaluation.Failure analysis investigation was unable to reproduce or confirm the reported failure.Visual inspection was performed.The arm was installed onto the system and powered up.Sine cycle and a test drive were performed without any issues.Tests performed via matlab passed.There was no trouble found.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.A review of the logs was performed and the procedure date and system information were confirmed.Based on the information provided at this time, this complaint is being reported due to the following conclusion: 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.

• Brand Name: DAVINCI SI
• 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: 13781270
• MDR Text Key: 287263339
• Report Number: 2955842-2022-10630
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2012
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 92 KG