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

Model Number 381121-28

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/05/2024

Event Type  Injury  

Event Description

The reported event was after a da vinci-assisted radical prostatectomy (with lymphadenectomy) surgical procedure, a procedure when the ground pad was removed from the patient's shoulder a wound was seen.The sites or director reported the grounding pad was placed on the patient's left posterior shoulder; the patient was positioned in a steep trendelenburg position for approximately 10 hours long.The surgeon reported the size of the wound was slightly larger than a quarter, treated with local wound care and has healed.He said the cause of the wound is unknown.There was no malfunction of the davinci system during the procedure.

Manufacturer Narrative

The reported event was addressed by an intuitive surgical, inc.(isi) field service engineer (fse) going to the customer site to further investigate the reported event.The reported event was unable to be reproduced.Preventative maintenance was performed; the system was tested and verified as ready for use.The complaint was not confirmed based on the field evaluation.Review of the logs show that all energy instruments that were used in this procedure were reused in subsequent procedures with no reported complaints created.

• 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: 18818642
• MDR Text Key: 336685085
• Report Number: 2955842-2024-11992
• Device Sequence Number: 1
• Product Code: NAY
• 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,User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-28
• Device Catalogue Number: 381121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male