MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ROBOTIC XI 30 DEGREE ENDOSCOPE; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 470027

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

Error was identified with the robotic xi 30 degree endoscope.After multiple attempts to troubleshoot the scope failed.Fda safety report id # (b)(4).

• Brand Name: ROBOTIC XI 30 DEGREE ENDOSCOPE
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 12568804
• MDR Text Key: 274736604
• Report Number: MW5104338
• Device Sequence Number: 1
• Product Code: NAY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1