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

Model Number 381121-41

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was addressed with phone support.The customer power cycled the system to resolve the issue.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

Event Description

It was reported that during a da vinci-assisted general colorectal surgical procedure, the procedure was converted to open surgery since the surgeon was not able to continue with the da vinci system.The issue was not with the da vinci system.The procedure was converted to open surgery with no reported injury.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was converted to an open surgery.The procedure was converted due to extensive adhesions.It was not converted due to intraoperative complications.There was no patient injury.A da vinci system was functional.No troubleshooting was performed.The system was inspected prior to use.No issues noted during system setup.There was no post-operative complications.

• 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: 18519764
• MDR Text Key: 332943378
• Report Number: 2955842-2024-10177
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-41
• 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: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.