MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication cannot be determined.A follow-up mdr will be submitted if additional information is obtained.System logs could not be performed at this time because there is insufficient event information.The procedure name, type, surgeons name and product details were not provided.Section d4 material number, batch/ lot number, serial number and udi number is unknown.Section e, unknown site name, first name, last name, and contact information.

Event Description

On 24-jan-2024, intuitive surgical, inc.(isi) received mw5150169 stating: the reported event was a postoperative duodenal segment staple line leak, which required a second operation 20 days after the initial robotic-assisted procedure.The area of the leak was stapled via the use of a covidien stapler.

• Brand Name: DA VINCI
• Type of Device: DA VINCI
• 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: 18766234
• MDR Text Key: 336057776
• Report Number: 2955842-2024-11455
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.