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

Model Number 380652-50

Device Problem Defective Component (2292)

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

Event Date 03/14/2022

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.Review of the site¿s system logs confirmed the occurrence of a cleared non-recoverable code 26002.As part of investigation, fse further investigated the issue of the user being unable to control the universal side manipulator (usm) arm and confirmed informational code 32100 due to suspect parts on the patient side cart (psc) - faulty proximal inner setup joint (suj) and usm arm 3.No system issue related to any of the surgeon side consoles was confirmed.The fse addressed the issue after replacement of the faulty parts.The system was further tested, operated without error and confirmed to be within specification.The system was verified as ready for use.Isi has received the usm arm and suj involved with this complaint; however, the evaluation is not completed yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.A review of the site's complaint history found no additional complaints related to this complaint.No image or video was available for review.System log/technical review: verification via rfe logs confirms the occurrence of a procedure on the reported event date matching the documented event details.No further review is required as the logs were reviewed and analyzed as part of the isi tse and isi fse's investigation.This complaint is being classified as a reportable event due to the following conclusion: during the procedure, the surgeon observed an issue controlling the usm arm using ssc 2 and moved to ssc1 to regain control.A transient issue with the usm arm was experienced after the start of the procedure.Fse performed a system evaluation and confirmed a system issue due to faulty parts (usm arm 3 and suj).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 conversion/abortion.

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy w/ hysterectomy surgical procedure using a dual surgeon side console (ssc) setup, the system displayed a non-recoverable error 26002.The customer received phone assistance from the technical support engineer (tse).Troubleshooting was performed through a system power cycle and this cleared the error fault; however, once powered up the surgeon experienced an issue controlling the universal side manipulator (usm) arm using ssc 2 and moved to ssc1 to regain control.The user continued with the procedure using the same system.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter on 7th-april-2022: there is no additional information available at this time.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The unit was tested on an in house system and it passed normal mode.The following errors were found in the logs: 1007, 307, 25730 & 32100 pointing to the proximal set up joint (psuj).These reported errors were replicated on the psuj.The usm tested on patient side cart fixture test platform (pftp) and passed all required tests.Isi received the psuj involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed and replicated the reported complaint.The errors were confirmed via the logs.The unit was put on the pftp machine and failed the break test, a golden axes controller set up (acu) was installed passed all the tests in the pftp machine.The acu was installed back and the suj failed for break test again.The acu will be replaced as a fix.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 14109210
• MDR Text Key: 298704520
• Report Number: 2955842-2022-11032
• 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: Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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: 380652-50
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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 Sex: Female