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

Model Number 380652-30

Device Problem Unintended System Motion (1430)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted hysterectomy - benign surgical procedure, insertion on the universal surgical manipulator (usm2) was "limited." the customer received phone assistance from the technical support engineer (tse).Review of the system logs confirmed no error related to an arm or a system issue.The customer was asked to troubleshoot by verifying if the drape on usm2 was not restricting the insertion movement and to check if the usm2 cannula was not pulled out or pushed in too far.The customer checked the cannula remote center.Following this, tse instructed the customer to undock the usm2 and use usm1 to continue with the procedure.Usm1 was confirmed to have full range of motion.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

The customer received phone assistance from the technical support engineer (tse).Review of the system logs confirmed no error related to an arm or a system issue.The customer was asked to troubleshoot by verifying if the drape on usm2 was not restricting the insertion movement and to check if the usm2 cannula was not pulled out or pushed in too far.The customer checked the cannula remote center.Following this, tse instructed the customer to undock the usm2 and use usm1 to continue with the procedure.Usm1 was confirmed to have full range of motion.The isi field service engineer (fse) was contacted by the customer and the isi clinical sales representative (csr) who was at the customer site.Fse instructed the csr to perform testing of the system and confirmed no issue with any of the usm arm.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's complaint history found no additional complaints related to this complaint.No image or video was available for review.A review of the site's system logs for the reported procedure date was conducted by technical support when the customer called for troubleshooting assistance and no errors were found in the logs.An event verification confirmed the procedure was performed on the reported event date.This complaint is being reported as a reportable malfunction event due to the following conclusion: the usm2 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, 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 conversion/abortion.

• 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: 14107550
• MDR Text Key: 298661479
• Report Number: 2955842-2022-11027
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 0886874110720
• UDI-Public: (01)0886874110720
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-30
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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