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

Model Number 380652-41

Device Problems Visual Prompts will not Clear (2281); Power Problem (3010)

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

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse replaced the system power manager (spm), universal power distributor (upd), load sharing cable, and two medical grade power supplies (mgps).The patient side cart (psc) experienced loss of ac power stemming from the load sharing cable.Mgps #2 had 418 errors prior to work being conducted.After installing the load sharing cable, both mgps' were displaying 417 errors.After removing the load sharing cable and returning the original single cables, the 417 error did not repopulate and the system did not experience any more ac power loss.Intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the device evaluation.The reported failure was replicated.There were four parts replaced from the system, and the reported error was replicated with the power supplies.One mgps unit was installed with another unit into an xi system, idle in normal mode, and run 10 power cycles with errors 417 in error log.This unit is 3 years old and will be scrapped.The second mgps unit was installed with another unit into an xi system, idle in normal mode, and run 10 power cycles with errors 417 replicated in err log.This unit is 3 years old and will be scrapped.The spm and the upd were tested on the pca test system and both passed the test without any issue.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was provided by the site for review.This complaint is being reported based on the following conclusion: it was reported that during a da vinci assisted procedure, the system faulted and could not be recovered.System unavailability after the start of a surgical procedure caused the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a procedure change.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.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer was getting the message "patient cart is running on battery".The surgeon mentioned that they were getting the battery message from the beginning of the case (approx.15 minutes in).The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer verify the wall outlet was working, and try another wall outlet with no change.Logs showed errors: 1152, 1167, 31220, 417.The surgeon also stated that the scope would move with the master controller, but the instruments did not move on any arms.The surgeon moved the scope to arm 3 from arm 2 and it still worked, but no instruments worked.The customer performed a hard reset on the patient cart and vision cart with no resolution.The tse had the customer reseat all instruments and sterile adapters but the issue persisted.The tse concluded that the power supply in the cart was faulty.The doctor stated that since they could not use the robot, the procedure would be converted to laparoscopic surgery.There was no report of patient injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12419528
• MDR Text Key: 271670833
• Report Number: 2955842-2021-11060
• 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,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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