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

Model Number 380652-41

Device Problems Device Reprocessing Problem (1091); Insufficient Information (3190)

Patient Problems Pneumonia (2011); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

No product has been returned to intuitive surgical, inc.(isi) for evaluation.There is no evidence in the site's complaint history to substantiate the report of a sterile processing department issue.A system log review did not reveal any system errors that would have caused or contributed to the reported event.

Event Description

It was reported that after a da vinci-assisted prostatectomy, the patient has been experiencing ¿excess protein in blood and recurring pneumonia.¿ the patient ¿heard¿ from someone at the california department of health that there have been issues with improper sterilization of da vinci instruments in sacramento (where his surgery took place) and believes this could be the cause of his medical issues that started after his procedure.

• 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: 19075842
• MDR Text Key: 339774578
• Report Number: 2955842-2024-13179
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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