MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; ENDOSCOPE

Model Number 470027-62

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

The endoscope used during the da vinci-assisted surgical procedure has not been returned to isi.Therefore, the root cause of patient¿s intra-operative complication cannot be determined at this time.A return material authorization (rma) was issued to the customer requesting to have the isi device returned; however, isi has not received the endoscope to confirm/identify any reportable failure mode(s).Isi has made several attempts to obtain the endoscope with no success.Furthermore, a review of the instrument log for the 8mm endoscope (pn: 470027-62, sn: (b)(4)) associated with this event has been performed.Per logs, the endoscope was last used on (b)(6) 2019 on system sk1557.The alleged event occurred on 29-may-2019, indicating the endoscope was used in subsequent procedures after the reported complaint.A review of the codes on 29-may-2019 was performed, indicating no errors related to the reported complaint.Site history review: as of 29-june-2020, a review of the site's complaint history does not show any additional complaints related to this product.The da vinci xi surgical system user manual provides the following cautions: ¿caution: during surgery, avoid endoscope contact with tissue to prevent tissue damage due to excessive heat.¿ ¿caution: the distal tip of the endoscope may reach high temperatures during use.Avoid contact with skin, tissue, and clothing when the endoscope controller is turned on, as damage may occur.Do not attempt to clean the tip of the endoscope by wiping with tissue.The tissue can be damaged because of the heat, and the tip of the endoscope may develop tissue deposits that can decrease light output.¿ technical review: an isi clinical application manager performed a review and followed up with the site, providing the following information regarding the surgeon¿s process: the initial dissection to create the space going down to the thyroid is done with a laparoscopic harmonic ace device.The harmonic ace blade has the tendency to heat up to around 90 degrees celsius when activated at longer times (>4 sec).Furthermore, the surgeon was contacted for additional information, noting that prior to this event, the endoscope was rarely moved during cases for 2-3 hours.Since then, the surgeon has changed the approach by frequently changing camera views and cleaning the camera.Medical review: a review of the event was conducted by an isi medical safety officer and the following additional information was provided: the images of the burns appear to be a full thickness injury of the skin, which is consistent with the definition of a third-degree burn.The burns occurred in a patient who underwent a da vinci-assisted transoral endoscopic thyroidectomy, which requires the creation of a sub-platysma flap.It is unclear as to the cause of the full thickness skin necrosis.Two of the main factors related to the degree of a burn are the duration and amount of energy of the exposure.The full thickness burn or third-degree burn may have occurred during the creation of the sub-platysma flap using a traditional cautery pencil, using an energy device to perform the dissection during the transoral endoscopic thyroidectomy, pressure necrosis from the edge of trocar pressed up against the sub-platysma flap, or the tip of the camera in close proximity to the sub-platysma flap for an extended period of time.The susceptibility of the tissue to burn is based on the ability of the tissue to dissipate the energy that is being applied to it.Thin flaps are more likely to experience a burn injury as there is limited blood supply to dissipate the energy.Third-degree burns to the skin can be caused from exposure to water as hot as 120 degrees f for a period of 5 minutes.Based on the current information provided, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure,, a "vesicle" was identified on the skin of patient¿s neck.The surgeon attributed the ¿vesicle¿ to a burn injury that was caused by the high temperature of an endoscope.The burn injury was located on the anterior side of the patient¿s neck and was described as being 3rd-degree.However, the root cause of the customer reported failure mode is unknown.This report has been generated in response to fda inspectional observations dated 06-mar-2020.

Event Description

It was reported that after completion of a da vinci-assisted thyroidectomy procedure, the surgeon identified a "vesicle" which was possibly caused by a burn.On 27-june-2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the da vinci-assisted thyroidectomy procedure was performed on (b)(6) 2019.There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure.There were also no intra-operative complications.After completion of the surgical procedure, a "vesicle" was identified on the skin of the patient¿s neck.The surgeon attributed the ¿vesicle¿ to a burn injury that was caused by the high temperature of an endoscope.The burn injury was located on the anterior side of the patient¿s neck and was described as being 3rd-degree.As a result of the burn injury, the patient was prescribed an unspecified ointment.At the time of follow-up, the patient was still treating the burn.

• Brand Name: DAVINCI XI
• Type of Device: ENDOSCOPE
• 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: 10212443
• MDR Text Key: 196957777
• Report Number: 2955842-2020-10609
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K171426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470027-62
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention