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

Model Number 380652

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

Patient Problem Burn(s) (1757)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root causes of the reported operative complications cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A system and instrument log review cannot be performed due to lack of system, procedure, and instrument details.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: within the journal article titled, ¿utilization of silicone sheet as a protective guide during transoral robotic tongue base surgery¿ it is noted that an unspecified number of patients sustained noticeable thermal injury to the epiglottis by visual inspection and one patient had subjective dysphagia from epiglottic scarring.At this time, the root causes of the operative complications are unknown.

Event Description

Intuitive surgical, inc.(isi) became aware of a ¿clinical techniques and technology" article titled, ¿utilization of silicone sheet as a protective guide during transoral robotic tongue base surgery¿ (volner, k., mostales, j.C., et al., 2021).Within the journal article, operative complications involving a da vinci surgical procedure were noted: ¿ten patients underwent tors bot resection and/or palatine tonsillectomy with the use of a silastic sheet.The placement of the silicone sheet was straightforward and easy to manipulate during the case.Moreover, the et tube was well protected from electrocautery tools during dissection.By visual inspection, no significant injury to the epiglottis and/or posterior pharyngeal wall was noted following each case.By comparison, 6 patients underwent bot reduction without the use of silicone sheet prior to the inception of the technique.Most had noticeable thermal injury to the epiglottis by visual inspection.One patient had subjective dysphagia from epiglottic scarring.Figure 3 demonstrates 1 case of particularly notable epiglottis thermal injury.¿ intuitive surgical, inc.(isi) contacted the surgeon/author and obtained additional information regarding the reported event: there was no allegation that a malfunction of a da vinci system/instrument/accessory occurred during the surgical procedures involved with the operative complications.In regards to the cause of the burns, the author explained, ¿it¿s combination of anatomy, difficulty accessing the area.And hence the silicone sheet to protect the epiglottis and surrounding structure; and to guide during dissection.It¿s become a standard practice for us now.¿ there was no medical intervention rendered to the patients for the burns.The author indicated that was no bleeding and no collision of instruments during the cases and no long-term complications/impacts secondary to the burns.Additionally, the author indicated that the complications would have occurred regardless of surgical modality, even without the robot.

• 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: 13529842
• MDR Text Key: 289484957
• Report Number: 2955842-2022-10250
• Device Sequence Number: 1
• Product Code: NAY
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES