MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-38

Device Problem Failure to Power Up (1476)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted right hemicolectomy surgical procedure, the customer reported that they were encountering issues with the e-100 during the procedure.The customer further stated that the e-100 indication did not light up when they connected the vessel sealer (vs) instrument.Prior to reporting the issue, the customer tried to power cycle the e-100 but the e-100 would not power off.They then tried to power cycle the e-100 from the breaker on the back of the e-100 but the e-100 powered up with an error.The customer elected to proceed with erbe delivering energy to the vs instrument.Onsite did not reflect any system or e-100 errors.The customer was not able to complete any troubleshooting while communicating with technical support since the surgeon was proceeding with the procedure.The customer will try to hard power cycle the system after the completion of the procedure.The clinical territory associate (cta) contacted technical support after the procedure for assistance with additional troubleshooting to try to resolve the issue.Cta stated that the power button and instrument leds were still red when the e-100 was powered on.With the system on, the technical service engineer (tse) had the cta hard power cycle the e-100, reseated the e-100 power cable on the back of the e-100, and reseated communication cable on the back of the e-100.Cta powered e-100 back on but with no resolve.Tse had cta hard power cycled the vision side cart (vsc), hard power cycled e-100 again, reseated communication cable to other end going into the back of the personality module vision acquisition (pmva), and powered the system back on.The system powered up normally but when the cta powered e-100 back on, the issue returned.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the e-100 was powered on prior to the procedure but would not function during the case.The customer plugged the vision side cart (vsc) into the erbe.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse replaced the e-100 due to power issues.The system was tested and verified as ready for use.The e-100 was returned and evaluated by the failure analysis (fa) team.The reported failure could not be replicated.The unit was installed onto the test system and it worked well with the synchroseal instrument installed.The fa team used the synchro seal with a saline dipped gauze in the jaws and fired the yellow pedal/synced activations and cut/seal about 100 times and the e-100 worked well without any issues.The unit passed with 10 power cycles and is in good condition.A review of the site's complaint history does not reveal any related complaints involving this product and/or this event.No image or procedure video was provided for review.This complaint is considered as a reportable malfunction due to the following conclusion: the electro-surgical generator unit (esu) was replaced after the start of the procedure and the surgeon was able to continue with the procedure robotically with a backup esu.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.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 13954539
• MDR Text Key: 297544600
• Report Number: 2955842-2022-10820
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-38
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White