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

Model Number 380652-46

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 11/15/2021

Event Type  Death  

Event Description

It was initially reported by a nurse from the site that during a da vinci-assisted pulmonary wedge resection, the patient's pulmonary artery was torn as a result of a robotic arm that had allegedly drifted and the patient expired.The intuitive surgical, inc.(isi) clinical sales representative (csr) obtained the following information from the nurse and console surgeon¿s partner: the nurse was reportedly not present during the case; however, she corresponded with the console surgeon who reportedly indicated that he no longer believes the event was caused by unexpected arm movement of the patient side cart (psc) and thinks the event was somehow caused by him.The console surgeon¿s partner speculates that the console surgeon hit the arm swap button without realizing it, inadvertently moved the retracted arm, and damaged the pulmonary artery with the installed stapler instrument.The console surgeon¿s partner said there was a stapler instrument across the pulmonary artery that was ready to fire but had not yet been fired.It is unknown how the console surgeon¿s partner became aware of the event details or if he was present during the case.

Manufacturer Narrative

Based on the current information provided, the cause of the intra-operative complication cannot be determined.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The initial reported complaint that a robotic arm had drifted or moved unexpectedly was not confirmed based on the field evaluation. the fse visually inspected the system and did not notice any damage.The fse inspected all universal surgical manipulators (usm) and did not notice any physical damage, with the exception of scratches on covers on all usm's (cosmetic only).No major damage to the usms were identified.The fse verified that the head sensors on both surgeon side consoles (ssc) were working properly.The fse also verified that the sterile adapters engaged properly on each usm and seated correctly.All sensors were found to be functioning properly.The system was tested and verified as ready for use.A review of the site's system logs has been performed by an isi failure analysis engineer (fae) for the procedure in question.No errors were identified in the system logs in relation to non-intuitive movement or drifting of arms.The instrument logs show that one sureform 45 instrument was used and fired 1 blue reload.The firing was completed with no pauses for compression per the logs.A stapler 30 curved-tip instrument was installed 5 times but only fired 1 reload (white), which occurred on install #3.The firing of the white reload was completed per the logs.The last install of the stapler 30 curved-tip instrument, did not have any clamp or fire attempts.A second white reload was installed but was never fired.All multi-use instruments used in the case have been used in subsequent procedures with the exception of the single-use instruments and the following instruments: permanent cautery spatula (pcs), long tip forceps, sureform 45, and fenestrated bipolar forceps (fbf).The fbf had 0 lives remaining after the case was performed.As of (b)(6) 2021, a review of the site's complaint history did not find any related complaints associated with the instruments used during the procedure.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the pulmonary artery was injured and the patient subsequently expired.After the event occurred, an fse inspected the system and was unable to reproduce the initial allegation by the customer that an arm drifted or moved unexpectedly.At this time, the cause of the intra-operative complication is unknown.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h10.A medical review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer and the following information was provided: "based upon the information presented in the description of events, the patient died during a da vinci-assisted pulmonary wedge resection due to an injury to the pulmonary artery.The pulmonary artery reported to have been torn.It is likely that the torn pulmonary artery led to a significant hemorrhage leading to the patient¿s death.The cause of the pulmonary artery injury is not known.The surgeon indicated, via a nurse at the site, that he does not believe that the pulmonary artery injury was due to a drifting arm.However, the surgeon did not indicate what he believed to have caused the injury.".

• 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: 12995502
• MDR Text Key: 282179977
• Report Number: 2955842-2021-11738
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES