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

Model Number 380652-50

Device Problem Unintended System Motion (1430)

Patient Problem Hematoma (1884)

Event Date 03/21/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted cholecystectomy procedure, the system arms, especially arm 4, would drift when clutched.While the or staff was docking the system, the cannula for arm 4 scraped the patient's mesentery, resulting with a hematoma.The intuitive surgical, inc.(isi) clinical sales manager (csm) called in the complaint to isi technical support after completion of the case.She acknowledged that the da vinci system was used on an unlevel floor.The isi technical support engineer (tse) explained that gravity will cause the arms to move the system is used on an unlevel floor.On 29-mar-2022, isi contacted the surgeon of this procedure and additional information was obtained about the complaint: the surgeon reported that the patient was taken back to surgery on post-operative day (pod) #1 for a laparoscopy procedure and laparotomy with evacuation of a hematoma and to control a bleeding vessel.There was reportedly a hematoma with bleeding in the omentum extending into the transverse mesocolon.The patient received one unit of blood due to this event.The surgeon reported that this hematoma was not apparent during the initial da vinci-assisted surgical procedure.There was no visible evidence of a trocar injury, and no hematoma was visible by the end of the procedure.The surgeon reported that there is no concern of this event causing any long-term complications with the patient.The patient was discharged home in stable condition after a three-day hospital stay.The surgeon reported that the hematoma appeared to be caused by blunt force rather than a penetration.The surgeon said this injury could have been caused by excessive force or movement applied to the trocar while docking to the system.The surgeon clarified that the docking process for arm 4 is particularly difficult due to the upper arm assembly swinging.The surgeon explained that the person docking arm 4 has to divert their attention to keeping the arm stable while connecting to the trocar.On 01-apr-2022, isi contacted the surgeon again and obtained the following additional information about the complaint: arm 3 and its trocar were in the umbilicus.Arm 4 and its trocar were in the left upper quadrant (luq).Both of these trocars were isi brand, 8mm trocars.The surgeon reported this is his routine set-up of the arms for his cholecystectomy procedures.The surgeon said the arms will experience a ¿swinging motion rotating around the flex joint.This swinging has to be counteracted to keep the docking port in line with the trocar, we¿re trying to connect to; excessive force applied to the hand holding the robot arm can lead to involuntary force/movements applied with the other hand holding the trocar.¿ the surgeon said they have established a routine of having two people dock each of the arms due to this reported arm movement.One person will hold the arm, preventing it from swinging, while the other person docks the arm to the trocar.The surgeon provided two theories for why this reported arm movement may be occurring: the robot may be on unleveled flooring or the upper boom may be out of balance.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication has been deemed to be unintended use error as the system was used on unleveled floor.Arm 3 has been replaced due to failing the pot range insertion axis test.Isi has received arm 3.However, failure analysis investigation of arm 3 has not been completed as of the date of this report.A follow-up mdr will be submitted if additional information is obtained.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced usm3 as it failed the universal surgical manipulator (usm) pot range insertion axis test.The fse found the reported arm drifting issues while clutched were directly related to the system being used on unleveled floor.The system was tested and verified as ready for use.The system logs for this event were reviewed by an isi advanced failure analysis engineer and the following information was obtained: "that procedure only had one error which was a class 0 (system service advisory (no fault reaction)) rfid error (31088).This would just be that the usm was unable to read the instrument.This could have been fixed by reseating the instrument or trying a new instrument.There are no errors that would suggest anything wrong with the system." three videos and one image were obtained from the customer for this event.The image shows a room in which the da vinci system is contained and presumably used to perform procedures in.The image contains text showing which direction the floor is slanted.The three videos show the universal surgical manipulators (usm) being clutched and beginning to drift.Particularly, arms 3 and 4 drift further and faster than arms 1 and 2.The conversation in the video indicates that the person clutching the usm's is not attempting to drift the arms laterally, but that this movement is due to the slanted floor on which the system is on.This event is being reported due to the following conclusion: during a da vinci-assisted cholecystectomy procedure, arm 4 drifted while connecting the arm to the cannula.The surgeon reported that this event contributed to a hematoma that required a secondary procedure to resolve.

• 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: 14190909
• MDR Text Key: 294644266
• Report Number: 2955842-2022-11205
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2021
• 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: 62 YR
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White