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

Model Number 400180-15

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2023

Event Type  Injury  

Event Description

On 08-feb-2024, intuitive surgical, inc.(isi) received user facility medwatch report 1402760000-2023-8010 stating: during a robotic myomectomy surgery, the disposable robotic sleeve came off the robotic monopolar scissors.A wire was noted to be sticking out of the side.A small piece of the orange sleeve on the instrument was ripped.The vendor rep was notified.Intuitive surgical, inc.(isi) attempted follow-up to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Isi has not received a device to perform failure analysis investigations.Additional information is being gathered to determine the contribution of the device to the customer-reported 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: 18830304
• MDR Text Key: 336862024
• Report Number: 2955842-2024-12012
• Device Sequence Number: 1
• Product Code: NAY
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-15
• Device Catalogue Number: 400180
• Device Lot Number: I84230601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Black Or African American