MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Reproductive System or Breast Problem (4513)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

A product was not received for failure analysis evaluation.There was insufficient procedural information to perform further advanced log investigation(s).

Event Description

On 07-nov-2023, intuitive surgical, inc.(isi) received user facility report 2100090000-2023-8008 stating: "loss of spatial orientation and visual cues in the setting of normal bilateral ovarian anatomy led to the removal of the unintended ovary.Suggestion: explore the feasibility of adding right and left on the screen within the console of robotic surgical equipment.".

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 18278983
• MDR Text Key: 329886365
• Report Number: 2955842-2023-20856
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/06/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 94 KG