MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that after a da vinci-assisted (unknown) surgical procedure, a patient developed a staple line bleed from one of the anastomosis sites, after using a sureform stapler instrument.The current clinical sales representative (csr) was not the site's csr at the time of the reported event; and was only told about it, from the surgeon, after the fact.The surgeon stated the staple line bleed happened in the last four years.It's unknown if the stapler used was a 45 or 60 sureform stapler instrument and the color of the reload/s are unknown.Unknown how the procedure was completed.

Manufacturer Narrative

The sureform stapler instrument involved with this reported event is not being returned; therefore, failure analysis investigations cannot be performed.The following information for this event is unknown: event date, system serial number, instrument part and lot numbers.Due to this missing information, instrument and system log reviews could not be performed.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 18093307
• MDR Text Key: 327644490
• Report Number: 2955842-2023-20104
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/08/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.