MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE SURGICAL ROBOTIC ARM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 380900-10

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Davinci si robot arm #1 displaying amber color upon docking with "instrument arm not free to move" error displayed.Davinci helpline direction to reboot components ineffective.Service ticket placed.Procedure performed laparoscopically without robotic assistance.Fda safety report id# (b)(4).

• Brand Name: INTUITIVE SURGICAL ROBOTIC ARM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 11505963
• MDR Text Key: 240732057
• Report Number: MW5100032
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380900-10
• Device Catalogue Number: M0443809001006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR