MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. LARGE XI ROBOT NEEDLE DRIVER VERSION 12; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problem Break (1069)

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

Event Date 06/23/2022

Event Type  malfunction  

Event Description

During surgery robot needle driver wasn't working and when inspected closer the wheel broke and fell off.It was returned to the manufacturer.Fda safety report id # (b)(4).

• Brand Name: LARGE XI ROBOT NEEDLE DRIVER VERSION 12
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 14914637
• MDR Text Key: 295360524
• Report Number: MW5110654
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male