MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-36

Device Problem Output Problem (3005)

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

Event Date 02/27/2024

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.Based on the field evaluation, this reported event was confirmed.The isi fse was able to replicate the reported issue and replaced the integrated electrosurgical unit (iesu) to resolve the issue.The system was tested and verified as ready for use.The unit was returned for failure analysis, and the reported failure (error c-43/c-00) was confirmed and reproduced.The unit was placed on an in-house system and run in normal mode.The complaint was confirmed based on failure analysis, which indicates that the device may have contribute to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted radical without lymphadenectomy prostatectomy surgical procedure, the integrated electrosurgical unit (iesu) was faulting when firing the monopolar energy.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and found c-34 errors for the iesu.Prior to calling in the customer had swapped energy cords and instruments and the issue remained.The isi tse had the customer power cycle the erbe, and the error persisted.The customer was in the process of getting another vision cart to replace it.The site was completing the procedure with no reported injury.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 18966391
• MDR Text Key: 338455177
• Report Number: 2955842-2024-12464
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-36
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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