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

Model Number 381121-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.An isi field service engineer (fse) investigation was completed.The fse confirmed with the customer that the problem was resolved on the phone during technical support.Site history review was conducted on 21-oct-2020, and did not show any additional complaints related to this event.System error log review was conducted during the support call, and confirmed the following errors: 23, 40, 40084, 25721, and 41014.A review of the instrument logs was performed on 21-oct-2020 for a procedure on (b)(6) 2020 on system sk1481.While none of the reusable instruments used in the case have been used in subsequent procedures, a site history review shows no complaint filed against the instruments.No image or video clip for the reported event was submitted for review.An isi clinical development engineer (cde) noted that bleeding is an expected part of prostatectomy procedures and can vary from patient to patient.A standard amount of blood loss was reported and the patient did not require a blood transfusion.Further review was conducted by an isi advanced failure analysis (afa) engineer and found that the logs reflect what the customer reported: two instances of error patterns that reflect a loss of communication between the vision side cart (vsc) and one of the surgeon side consoles (ssc), specifically ssc2, in a pattern that is reflective of loss of power at the ssc or a blue fiber being pulled out.Based on the current information provided, this complaint is being reported because the patient reportedly experienced 1,000 ml of blood loss during a da vinci-assisted prostatectomy procedure.There was no allegation of an issue with the da vinci system, instruments, or accessories.While there was no report of medical intervention, no blood transfusion was administered, and there were no other complications, at this time, the root cause of the intra-operative complication is unknown.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was initially reported that during a da vinci-assisted prostatectomy procedure, there was a non-recoverable 41014 error on the system.The intuitive surgical, inc.(isi) clinical territory associate (cta) contacted an isi technical support engineer (tse) from offsite to report the issue.Live system logs revealed errors: 23, 40, 40084, 25721.When the cta arrived on site in the operating room (or), the or staff had already rebooted the system and the system was working normally without errors.The cta confirmed that all fiber cables were secure.There was no report of patient injury but the or staff stated that during the issue, the patient had lost around 1 liter of blood but did not note the cause of the bleeding or when it occurred.The procedure continued and was completed as planned robotically.The patient allegedly lost 1 liter of blood.On 21-oct-2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: it was confirmed through follow-up that during a da vinci-assisted prostatectomy procedure, the system presented with errors.One of the surgeon side consoles (ssc), ssc2, had become unplugged by operating room (or) staff.Just after that happened, an or staff member stepped on a fiber cable.A non-recoverable 41014 error presented and live system logs confirmed errors 23, 40, 40084, and 25721.The or staff rebooted the system and the system then worked ¿normally¿ without errors.The customer ¿removed everything¿ so that they could reboot the system.Each of the two system reboots took ¿roughly one and a half minutes or longer to recover¿." there was approximately 1,000 ml of blood loss reported by a surgeon as a ¿standard¿ amount of blood loss given that this was a prostatectomy procedure and some patients are expected to have more bleeding than others.There is no allegation of an instrument or accessory malfunction and the system errors were attributed by the surgeon to or staff cord mismanagement.It was unknown if the system errors or system recovery time contributed to the amount of bleeding the patient experienced as it was unknown when, during the procedure, that the blood loss occurred.The procedure completed robotically.No medical intervention was required, no blood transfusion was administered, and there were no other complications.The patient is reported as ¿doing well¿ and was expected to be discharged home on the afternoon of (b)(6) 2020.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10834343
• MDR Text Key: 217932669
• Report Number: 2955842-2020-11194
• 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: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-28
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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
• Patient Outcome(s): Other