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

Model Number 380652-40

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that during a da vinci-assisted pulmonary wedge resection surgical procedure, the sureform 45 curved-tip stapler instrument sheath tore as it was being removed from the patient.The event occurred with the sureform 45 curved- tip stapler instrument the targeted tissue was the right lower portion of the lung.The stapler crossed over another instrument and due to the curved-tip of the stapler the angle was not able to give a good exposure for use.When the surgeon attempted to pull the stapler out to reposition the sheath of the sureform 45 curved-tip stapler instrument tore on while the stapler was being removed.No tissue damage occurred during the event or throughout the procedure.No fragments fell due to the sheath tearing.The surgeon discontinued the use of the stapler.The procedure was converted to an open thoracotomy due to anatomy, the lower portion of the right lung was the target tissue and the surgeon did not have the proper exposure that was required to free the lung enough to safely staple that section.There was no error or complication with the da vinci system.The patient is recovering well.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

The patient was a (b)(6) year old male, 94.6 kg, bmi 29.1, caucasian medical history: b- cell lymphoma, hx smoking 1.5ppd x 25 years, covid, extensive mediastinal lymphadenopathy.

• 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: 18230766
• MDR Text Key: 329316562
• Report Number: 2955842-2023-20628
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 380652-40
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White