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

Model Number 400180-14

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

The tip cover accessory was an incidental return included with rma 301397350010 under patient identifier (b)(6) for a tip cover accessory falling inside a patient.No allegation was made against this product.Intuitive surgical inc.(isi) followed up with the customer and obtained the following information: the mcs tip cover accessory did not fall into the patient.The mcs tip cover was melted on the sides after use.

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the monopolar curved scissors (mcs) tip cover accessory.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) tip cover accessory was analyzed, and the complaint was not confirmed by failure analysis.The mcs tip cover was returned unopened.The mcs tip cover accessory was placed on an in-house mcs instrument and then installed onto an in-house system.The instrument moved with full range of motion in all directions.The tips opened and closed properly.The tip cover accessory remained properly seated on the instrument.No product issue was identified.

• 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: 17982363
• MDR Text Key: 326232227
• Report Number: 2955842-2023-19481
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)L83230504
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• 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: L83230504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• 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.