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

Model Number 380652-22

Device Problem Failure to Power Up (1476)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The field service engineer (fse) replaced the system power manager (spm) (372192-11) to resolve the reported issue.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the system power manager (spm) involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the reported complaint.The spm was installed onto the printed circuit assembly (pca) test system where it was programmed and turned on.It was noted the patient side cart (psc) would not power on with the power button flashing blue.A review of the site's system logs for the reported procedure date was conducted by an isi technical service engineer (tse).Investigation revealed the following possible related system errors: 23|wheel hardware fault: msc reported a hardware fault in the wheel communication.Pointing to rear core fiber port ( top port ), 40|gbit hardware fault: the msc node on icc reported a gbit communication error on gbit instance 0 ( core: top blue fiber port, master, left video and comm ), 40084|a comm link from the vdc in icc is down.Message destination was tpc1 in console touchpad, and 50007|msc reported pcmcia busy timeout.(timeout in get data from node uce1, cmd:0x4001007a.) no image or video clip for the reported event was submitted for review.This complaint is being reported due to the da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if the reported malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the customer found the patient side cart (psc) would not turn on.The customer informed the intuitive surgical, inc.(isi)technical service engineer (tse) that they had experienced a power outage in the operating room (or).After, the customer stated the area surrounding the psc power button was flashing blue and the button itself was orange.The customer stated the fiber led on the psc and the third jack on the vision side cart (vsc) were off.Then, the tse had the customer verify the fiber cables were good.The customer stated they had three solid green battery led¿s on the psc, but the psc would not turn on.The tse had the customer turn off the robot, unplug the power cord to the psc, and try to start on battery power, and nothing occurred.It was noted the customer had converted to laparoscopic surgery prior to calling into technical support.The customer requested a field service engineer (fse) follow up as soon as available.There was no reported injury or harm.Isi followed up with the robotic coordinator and obtained the following additional information: the robotic coordinator reported that the system was inspected prior to starting and nothing out of the ordinary was observed.However, when the surgeon went to dock the patient side cart (psc) the system had a 252 error.At the time, the procedure was just beginning, and the surgeon did not want to wait to troubleshoot and decided to convert the procedure to laparoscopic.While the surgeon continued with the case laparoscopically, the staff continued troubleshooting with technical support and were able to get the system up and running.When the customer was ready to close the vaginal cuff, the surgeon wanted to use the system; however, when moving the system the 252 error occurred.The robotic coordinator confirmed the surgeon closed the vaginal cuff laparoscopically.The surgeon did not know why the reported issue occurred.The patient did not experience any post-operative complication due to the reported issue.There was no video/image available for review.The robotic coordinator confirmed the procedure was completed laparoscopically with no patient injury or harm.

• 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: 12164647
• MDR Text Key: 261507490
• Report Number: 2955842-2021-10787
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-22
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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: 48 YR
• Patient Weight: 106