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 Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Death  

Manufacturer Narrative

A review of the site history logs for the instruments used during the reported procedure found that the following multiple-use instruments have been used in subsequent procedures with no reported complaints: endoscope plus 30 degree and mega suturecut needle driver.Additional multiple use instruments, monopolar curved scissors and force bipolar have not been used again, and have no complaints reported.Review of the device history records for the instruments used during the procedure showed no non-conformances were identified.A system log review did not reveal any system errors that would have caused or contributed to the reported event.A review of the system logs for the three procedures performed subsequent to the reported event found no related errors.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that based on the available information, the patient in this report died due to unknown reasons after an outpatient inguinal and incisional hernia procedure after returning home.No intraoperative complications or events were reported and no allegation was made against any intuitive surgical product.The cause of death is unknown.Based on the information provided, insufficient information is available to determine if any intuitive surgical products or instruments contributed to this event.Section b2: date of death is estimated in accordance with information that patient was discharged home, spouse went to pharmacy and returned to find patient deceased.

Event Description

It was reported that after an uneventful da vinci assisted inguinal and incisional hernia repair, the patient expired.The procedure was performed outpatient.After returning home, the patient's spouse left to pick up a prescription.Upon return home with the prescription, the patient was found deceased.The cause of death is unknown.The procedure was completed robotically and there were no reported malfunctions of a da vinci product.During follow up with the surgeon, the clinical sales representative (csr), was informed that the death was not related to the da vinci system and therefore no additional information would be provided.The surgeon also told the csr that although the cause of death is unknown, it is believed that it may have been the result of undiagnosed cardiac disease.

• 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: 18380697
• MDR Text Key: 331174873
• Report Number: 2955842-2023-21576
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2023

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
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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 Sex: Male