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

Model Number 380652-37

Device Problem Activation Problem (4042)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

4315, 67.Based on the current information provided, the root cause of the patient¿s alleged bowel injury is unknown.Isi has attempted to contact the site to obtain additional information regarding the reported event.However, as of the date of this report, no new or additional information has been obtained.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site¿s system logs with a procedure date of 11/18/2019.No related system errors were found to have occurred based on the available logs.Based on the information provided at this time, this complaint is being reported due to the following: during a da vinci-assisted lar procedure, the surgeon claimed that the swap pedal on the ssc did not work and as a result, the patient sustained a bowel injury.However, at this time, it is unclear if the bowel injury required any medical intervention or repair.In addition, the root cause of the bowel injury is unknown.A fse inspected the da vinci xi surgical system and was unable to replicate the customer reported issue.No trouble was found by the fse during the evaluation of the system.

Event Description

It was reported that during a da vinci-assisted low anterior resections (lar) procedure, the patient sustained a bowel injury while the surgeon was attempting to activate energy with a harmonic ace curved shears instrument.The surgeon claimed that the swap pedal on the surgeon side console (ssc) did not work and as a result, energy from a fenestrated bipolar forceps instrument was inadvertently activated instead.Per the da vinci xi system user manual, "pressing the swap pedal allows the surgeon to select which of the instruments is actively controlled by the hand controls." the user manual also states the following: ¿when instruments are reassigned, the system takes the instruments out of surgeon control, notifies and prompts you with an icon and associated message: ¿press ¿arm swap¿ pedal to activate arm¿.The icon or symbol is visible to the user and indicates that instruments have been reassigned.The user is instructed to tap/hit the ¿swap¿ pedal to acknowledge the message on the screen and continue.During the reported event, the surgeon indicated that the patient¿s bowel was burned and a hole was identified.However, it is unclear what medical intervention, if any, was administered due to the bowel injury.The surgeon also mentioned that there seemed to be a delay with the movements of the robotics instruments during the entire surgical procedure.The procedure outcome is unknown at this time.However, the surgeon noted that the patient is doing fine.After the event occurred, an intuitive surgical, inc.(isi) field service engineer (fse) performed a system check at the site.The fse installed testing instruments on the various universal surgical manipulators (usm) on the patient side cart (psc) and was able to swap instruments from usm to usm.The fse used the foot pedals on the psc without any problems.The fse tested the system and verified that it was ready for use.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 9411665
• MDR Text Key: 169217895
• Report Number: 2955842-2019-10940
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention