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

Model Number 400180-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted general surgery surgical procedure, the monopolar curved scissors (mcs) tip cover accessory fell into the patient.The surgeon retrieved the mcs tip cover accessory during the procedure and used a new mcs tip cover accessory to continue with the procedure.The procedure was completed as planned.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument and mcs tip cover accessory were inspected prior to use with no issue.The tip cover suddenly fell off when the surgeon was performing a passive bowel surgery.The tip cover was removed with laparoscopic forceps.The surgeon did not notice any issue with the mcs instrument functionality during the surgical procedure.The mcs instrument did not collide with any other instruments during the procedure.The mcs tip cover accessory appeared to be properly installed.No part of the orange surface was visible after the mcs tip cover accessory was installed.The mcs tip cover accessory was not installed beyond the orange surface.Installation tool and electrode cleaner carbotect were used.The surgical staff did not notice any damage on the mcs tip cover accessory, mcs instrument, or cannula after the event occurred.The tip cover will be returned, but the mcs instrument will not be returned.

• 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: 18970386
• MDR Text Key: 338506711
• Report Number: 2955842-2024-12534
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)L82230914
• 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,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: L82230914
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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