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

Model Number 380652-43

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported post-operative complications cannot be determined or is unknown.There is no allegation of a da vinci product malfunction.As a result, no products are expected for return and analysis.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was unable to be conducted at this time due to lack of instrument detail and lack of specific event/procedure detail.No image or video clip for the reported event was submitted for review.System or instrument log reviews could not be performed due to lack of system, procedure, and instrument detail.Based on the information provided at this time, this complaint is reportable due to the following: within the australian journal of otolaryngology titled, ¿staged neck dissection prior to trans-oral surgery provides a safe and effective treatment paradigm for early oropharyngeal carcinoma," post-operative complications stemming from a retrospective cohort analysis that was performed on data collected from 66 patients undergoing tors and neck dissection between july 2013 and july 2019 with one of two unspecified surgeons ¿using the da vinci system¿ were cited.The article noted that there were three post-operative hemorrhages, two of which required surgical intervention, and three pharyngocutaneous fistulas.At this time, additional event and procedure details, severity of complications, specific medical intervention required, and root cause of the alleged complications are unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

On (b)(6) 2021, intuitive surgical, inc.(isi) became aware of an (b)(6) journal of otolaryngology titled, ¿staged neck dissection prior to trans-oral surgery provides a safe and effective treatment paradigm for early oropharyngeal carcinoma¿ (cooper, l.N., crouch, s., et al., 2021).The article cited, ¿increasing evidence shows transoral robotic surgery (tors) is a feasible option in treating early oropharyngeal squamous cell carcinoma (scc),¿ and that ¿a retrospective cohort analysis was performed on data collected from patients undergoing tors and neck dissection between july 2013 and july 2019 in the gold coast health service district.¿ the article cited that, ¿all procedures were carried out by one of two unspecified surgeons and tors lateral oropharyngectomy was performed using the da vinci system (intuitive surgical inc, (b)(6) usa) either concurrently or as a staged second procedure within 7 to 14 days.¿ within the journal article, post-operative complications were noted: ¿there were three post-operative hemorrhages, two of the post-operative hemorrhages requiring surgical intervention were in the concurrent surgery group, whilst the one hemorrhage that occurred in the staged group was less severe and was managed conservatively.There were three pharyngocutaneous fistulas, with all fistulas occurred in patients who underwent concurrent surgery, no fistulas were recorded in patients who underwent staged surgery.¿ two post-operative hemorrhages were from tors and neck dissection and the third hemorrhage was from staged neck dissection and then tors.Isi has reached out to the author to obtain additional information but has not yet received a response.

Manufacturer Narrative

Refer to the following fields for updated information: g3, g6, h2, and h10.On (b)(6) 2021, author correspondence replied to follow-up attempts and the following information was obtained: "all performed on gc.No malfunction of da vinci.All normal post-op complications in otherwise uncompromised patients.".

Event Description

Refer to h10/h11 for follow-up information.

• 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: 12829653
• MDR Text Key: 284877806
• Report Number: 2955842-2021-11529
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-43
• 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: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• 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.