MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180-14

Device Problems Melted (1385); Arcing (2583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation.The mcs tip cover accessory was inserted onto an in-house mcs instrument and then functionally tested.The mcs tip cover accessory held its place and did not fall off during functional testing.The customer reported event of the mcs tip cover accessory falling off from the mcs instrument was not reproduced during functional evaluation.The follow-up information received from the site indicated that electrolube was applied during installation of the mcs tip cover accessory.Electrolube is not provided by intuitive surgical and is not suggested in the tip cover accessory or monopolar curved scissors instructions for use.The use of electrolube with the monopolar curved scissors has not been validated by intuitive surgical.The instrument was further investigated and an unrelated issue was identified.Visual inspection found localized melting on the distal end of the mcs tip cover accessory.This additional observation is indicative of arcing.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video or image was submitted to isi for review, and no additional technical analysis was conducted.System log investigation: review using the site name - kawasaki medical school hospital was performed and confirmed use of a monopolar curved scissors (mcs) instrument with lot# n12191011 / sequence 0073 on da vinci system (b)(4) during a procedure on the reported event date of (b)(6) 2020.Additionally, an instrument log review was performed on the mcs instrument lot# n12191011 / sequence 0073.Per logs, the instrument was used once with 2 remaining lives on (b)(6) 2020.Instrument was reused for subsequent procedures until meeting its end of life.Based on the failure analysis results, the decision tree was re-executed to indicate that this complaint is being classified as a reportable malfunction event due to the following conclusion: the tip cover accessory, when used as intended, provides insulation over a section of the endowrist monopolar curved scissors instrument so that radio frequency (rf) energy is only available at the instrument scissor tips.It was reported that during a da vinci-assisted radical cystectomy procedure, the user removed the monopolar curved scissors (mcs) instrument from the universal side manipulator (usm) arm; however, while removing the instrument, the mcs tip cover accessory got detached from the mcs instrument and fell inside the patient's body.The entire mcs tip cover accessory was retrieved and no known post-operative test performed.Another mcs tip cover accessory was installed into the same mcs instrument to complete the surgical task.The user completed the procedure.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: electrolube was applied during installation of the mcs tip cover accessory.During mcs instrument removal, the mcs tip cover accessory got detached from the mcs instrument and fell inside the patient's body.The entire mcs tip cover accessory was retrieved and no known post-operative test performed.No post-operative complication has been reported.Evaluation by failure analysis did not confirm nor reproduce the customer report of the mcs tip cover accessory getting detached from the mcs instrument.However, during investigation an unrelated issue was identified.The mcs tip cover accessory was found to have localized melting on the distal end.This complaint is being reported because the additional finding identified during failure analysis is indicative of arcing that could lead to unintended electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.This report has been generated in response to fda inspectional observations dated 06-mar-2020.

Event Description

It was reported that during a da vinci-assisted radical cystectomy procedure, the user removed the monopolar curved scissors (mcs) instrument from the universal side manipulator (usm) arm; however, while removing the instrument, the mcs tip cover accessory got detached from the mcs instrument and fell inside the patient's body.The entire mcs tip cover accessory was retrieved and no known post-operative tests were performed.Another mcs tip cover accessory was installed onto the same mcs instrument to complete the surgical task.The user completed the procedure.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: electrolube was applied during installation of the mcs tip cover accessory.During mcs instrument removal, the mcs tip cover accessory got detached from the mcs instrument and fell inside the patient's body.The entire mcs tip cover accessory was retrieved and no known post-operative tests were performed.No post-operative complication has been reported as of the date of this report.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• 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: 10609855
• MDR Text Key: 241928763
• Report Number: 2955842-2020-11024
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M90191003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES