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

Model Number 380652-41

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, error 32101 occurred.The site rebooted the system, but the error returned immediately.The technical support engineer (tse) instructed to perform a second reboot while turning the patient side cart (psc) circuit breaker off and performing an emergency power off (epo), but the issue did not resolve.The site deactivated the affected arm and continued with the case.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up on (b)(6)2022 and (b)(6)2022 and obtained the following additional information: system functionality was checked upon powering on the system.The system initially powered on without errors.Surgery was in progress for approximately 15 to 20 minutes when the issue occurred.The surgeon continued the procedure with three arms.The surgery was prolonged more than 45 minutes.The patient was 31 years old, date of birth (b)(6)1991, female, 146 kg, and had morbid obesity.No information was available regarding relevant tests.There was no ischemia time during the procedure delay.The procedure duration was two hours 33 minutes.

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the universal surgical manipulator (usm) due to error 32101.The system was tested and verified as ready for use.Isi has not received the usm for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.No image or video clip for the reported event was submitted to isi for review.Per log review, the following was confirmed: a gastric bypass (roux-en-y) was performed on system sk3281 on (b)(6)2022.This complaint is being reported due to the following conclusion: a usm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.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.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the reported failure.However, the error was confirmed via error logs/system logs.The unit was tested on an in-house system and failed normal mode.The unit was also tested on a psc fixture test platform (pftp) and passed chipencoder virtual absolute (cva) characterization, lissajous, sine cycle, and brake tests.

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: 15584629
• MDR Text Key: 306693922
• Report Number: 2955842-2022-14515
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 146 KG