MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; UNKNOWN

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer reported erratic movement with the instrument.There was no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the robotic coordinator stated she heard about the event a week later but not sure who reported it and therefore it is unknown what instrument it was related to.

• Brand Name: DA VINCI
• Type of Device: UNKNOWN
• 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: 18178122
• MDR Text Key: 328625432
• Report Number: 2955842-2023-20450
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES