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

Model Number 380652-43

Device Problem Failure to Sense (1559)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the universal surgical manipulator (usm) to resolve the issue.The system was tested and verified as ready for use.The complaint was confirmed based on the field evaluation.Isi has requested the usm for evaluation, but the product has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the instrument on universal surgical manipulator (usm) 1 was not recognized.The site continued the procedure with 3 usms.The site found a broken part on the usm carriage instrument sensor.The intuitive surgical, inc.(isi) technical support engineer (tse) checked the logs and found error 282 pointing to an issue with the usm tool sensors.The procedure was completed with no reported injury.Isi followed up with the robotics coordinator and obtained the following additional information: the problem was identified during the first connection of an instrument to the patient side cart (psc), just after docking the trocars.The system's functionality was checked and found to be error-free.The procedure was converted to laparoscopic surgery with no patient harm.

• 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: 18741977
• MDR Text Key: 335843323
• Report Number: 2955842-2024-11343
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• 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

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-43
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• 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