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

Model Number 400180-14

Device Problems Arcing (2583); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the reported complaint.The mcs tip cover accessory was found to have tearing at the mouth.The tears were axially aligned with the mcs tip cover accessory and measured from 0.076¿ in length.There were no signs of thermal damage present at the end of any tears.Tears at the mouth are most commonly caused by repeated thermal and mechanical stresses.The root cause is attributed to a component failure.An additional observation was also identified.Visual inspection observed a burn hole at the center of the mcs tip cover accessory.The burn measured 0.044" x 0.052" in length.There was no mcs instrument that was returned with the reported accessory.There was no thermal damage exhibited at either end of the mcs tip cover accessory.It is likely that the burn was caused by another energized instrument due to no thermal damage found at the ends of the accessory.The root cause is typically attributed to mishandling/misuse.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or video of the procedure was provided for review.This complaint is being reported due to the following conclusion: failure analysis observed a burn hole at the center of the mcs tip cover accessory.In the event the tip cover is compromised, it is possible for energy to discharge in an area other than the instrument tip.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, physical damage was found to the monopolar curved scissors (mcs) tip cover accessory.The procedure was completed.On (b)(6) 2022, intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following information: the customer confirmed a tear on the mcs tip cover accessory.Prior to its use, the customer indicated the mcs instrument and mcs tip cover accessory were inspected and no damage was observed.An installation tool was used to install the mcs tip cover accessory, without use of electrolube or lubricant.The mcs tip cover accessory was properly placed with no orange surface visible.The mcs instrument did not collide with another instrument during use.No fragments fell inside the patient nor was there any injury to the patient as a result of the alleged issue.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• 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: 14132090
• MDR Text Key: 298881705
• Report Number: 2955842-2022-11106
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)L90210330
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: L90210330 0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.