MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI XI PERMANENT CAUTERY HOOK SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 470183

Device Problem Crack (1135)

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

Event Date 04/23/2021

Event Type  Injury  

Event Description

Patient underwent a laparoscopic cholecystectomy with divinci xi robot. During the surgery, it was noted that there was a catching with the arm and could feel resistance. Robotic hook cautery malfunctioned therefore the robot was rendered incapacitated. It was discovered that the hook cautery had cracked on the proximal clevis and a small piece was unaccounted for. Fda safety report id# (b)(4).

• Brand Name: DAVINCI XI PERMANENT CAUTERY HOOK
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA
• MDR Report Key: 11759821
• MDR Text Key: 248777904
• Report Number: MW5101096
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/30/2021 Patient Sequence Number: 1