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

Model Number 380652-51

Device Problem No Device Output (1435)

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

Event Date 03/23/2022

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.The fse replaced universal surgical manipulator (usm) 1 to resolve the engagement issues.The system was tested and verified as ready for use.Isi received the usm involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed and replicated the reported failure of instrument recognition and engagement issues.The usm was tested on the system and failed normal mode.The usm triggered a ¿could not recognize the instrument¿ message for a large needle driver with a couple different sterile adapters.The system logs confirmed that the usm triggered a 282 error.The usm failed the carriage switches test.The axes controller, carriage rfid (accr) printed circuit assembly (pca) was switched with a test accr and the unit still failed the carriage switches test.The original accr pca was returned and the accr antenna was replaced with a test antenna; the unit passed the carriage switches test.The accr antenna was returned for aba testing, but the unit failed the carriage switches test again.The accr antenna will be replaced.The usm passed the direction test, sensor check, carriage lissajous, sine cycle, carriage friction test, friction test, brake test, carriage strength test, carriage/acm fan and fiber test.A review of the site's complaint history revealed that this record is related to the complaint documented under patient identifier (b)(6).No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: a universal surgical manipulator (usm) was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using three 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.Furthermore, upon visiting the site, the fse replaced the usm.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.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted ovarian cystectomy surgical procedure, the customer had engagement issues on universal surgical manipulator (usm) 1.The customer notified the clinical sales representative (csr) who reported the issue from offsite.The customer reseated the drape.The technical service engineer (tse) reviewed the system logs and noted error 282 indicating an engagement issue on usm1.The surgeon continued the procedure using usms 2, 3 and 4.The procedure was completed with no reported injury.Isi followed up with the robotics coordinator and obtained the following additional information: the robotics coordinator confirmed that the procedure was completed robotically without any injury to the patient by disabling usm1.The robotics coordinator stated that during a separate procedure (captured in patient identifier (b)(6)), the issue occurred at docking while attempting to install instruments on the usm.The arm was not receiving any instruments.To troubleshoot, the staff removed the instrument, checked for physical damage or obstructions, and found nothing.The staff attempted to reseat the instrument with no change.The staff then removed and replaced the drapes from usm1, still with no change.The staff continued with the three remaining arms.The robotics coordinator informed that the staff restarted the system between procedures.The same issue occurred at docking while trying to install instruments in the second procedures (captured in this record).Usm1 was disabled.The robotics coordinator informed that both procedures were ovarian cystectomy procedures.Patient demographic information was requested but unavailable.

• 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: 14190903
• MDR Text Key: 299076515
• Report Number: 2955842-2022-11203
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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