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

Model Number 400180-14

Device Problems Crack (1135); Material Split, Cut or Torn (4008)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the medical team noticed a crack in the monopolar curved scissor (mcs) tip cover accessory.There was no report of injury.Intuitive surgical inc.(isi) made multiple follow-ups attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

The monopolar curved scissors (mcs) tip cover accessory has been discarded and is not available for investigation purposes.Root cause of the customer reported failure mode was unable to be determined for this alleged issue.A review of the site's complaint does not show any additional complaints related to this product and/or this event.The customer provided an image of an mcs tip cover accessory that showed damage in the gray silicone portion.This complaint is being reported due to the following conclusion: the mcs tip cover accessory was damaged and had a tear on the gray silicone area.In the event the tip cover is compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized." failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns.

Manufacturer Narrative

Corrections can be found in the following fields: b3: event date additional information can be found in the following sections: g3, g6, h2, h6 and h10.Intuitive surgical, inc.(isi) followed up with the initial reporter and on 27-apr-2022 obtained the following additional information: the event date initially provided was incorrect.The correct event date is march 18, 2022.The monopolar curved scissors (mcs) instrument was inspected prior to use.The reporter confirmed there was no arcing and no thermal damage observed.No fragment fell inside the patient and the patient did not return to the hospital because of retained fragment in the body.The mcs tip cover accessory was replaced after the issue was detected; as a result, there was a procedure delay of approximately 5 to 10 minutes.The procedure was completed with the same mcs instrument without any additional problem.There was no patient injury as a result of the alleged issue.No additional information regarding the mcs tip cover accessory was provided.Patient information was not available.

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
• 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: 14173727
• MDR Text Key: 298993420
• Report Number: 2955842-2022-11180
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)L90210909
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: L90210909
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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