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

Model Number 380652-46

Device Problem Premature Activation (1484)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/19/2021

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.Site history review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.System error log review was conducted and found that there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against any of the instruments.Based on the information provided at this time, this complaint is reportable due to the following: the surgeon stated that there was no malfunction of a da vinci product and that the system and instruments worked as expected and as intended but the surgeon cited a safety hazard due to the close proximity of the system foot activation pedals.Medical intervention and a second surgery were required due to an alleged system design deficiency leading to the surgeon¿s use-error of the pedals and inadvertent activation of instrument cautery function.While the endowrist suction irrigator is not an electrosurgical instrument, the surgeon can activate it with the same pedals used to activate electrosurgical instruments.The instrument & accessory user manual states: the following caution should be observed: inadvertent electrosurgical energy may cause serious injury or surgical complications to the patient.It is important to ensure a full understanding of the da vinci xi system energy user interface and use caution when working near critical anatomy.At this time, the root cause of the customer reported failure mode cannot be determined or is unknown.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The catalog number and lot number are not applicable.The product is not implantable.It is unknown if reporter sent to fda.

Event Description

It was initially reported by the surgeon that during a da vinci-assisted cholecystectomy surgical procedure, as the surgeon was retracting the liver with an endowrist monopolar hook instrument and simultaneously using a suction irrigator to clean the area of fluids, the surgeon pressed the suction pedal but part of his foot hit the pedal for the monopolar hook instrument.This resulted in the surgeon activating both pedals at the same time which caused a ¿hole in the bile duct¿.The robotic procedure completed and bile duct repair and stent placement was performed in an unplanned procedure.On (b)(4) 2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: toward the end of a da vinci-assisted cholecystectomy surgical procedure (b)(6) 2021 on a (b)(6) year old patient on an xi system, as the surgeon was retracting the liver with an endowrist monopolar hook instrument in arm 4 and simultaneously using a suction irrigator in arm 2 to clean the area of fluids, the surgeon pressed the suction foot pedal but part of his foot inadvertently partially hit the energy activation pedal for the monopolar hook instrument.This resulted in the surgeon, ¿inadvertently activating the hook cautery¿ which caused a ¿hole in the patient¿s bile duct¿ which was one to two millimeters in size, where the common bile duct enters the liver, and an unspecified amount of bile leakage was visible.The surgeon stated that he inadvertently activated both the irrigation and energy activation pedals at the same time.The surgeon sutured the area and placed a drain to repair the bile duct injury during the same procedure and on (b)(6) 2021, a different surgeon performed an unplanned second procedure endoscopically that included the following surgical tasks: endoscopic retrograde cholangiopancreatography (ercp), bile duct stent placement, and a sphincterotomy.The second, endoscopic, procedure completed without incident.The patient was reported as ¿doing fine¿ and the patient has since been discharged home with no reports of post-operative complications.

• 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: 11325788
• MDR Text Key: 240341710
• Report Number: 2955842-2021-10134
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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 Age: 72 YR