MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI ROBOTIC MONOPOLAR SCISSOR COVER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  Injury  

Event Description

When removing the monopolar scissor from the robotic port, it was noted that the (disposable) cover tip was missing.Upon looking it was still in the trocar and torn.It was then removed and a new one was placed on the scissors.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: DA VINCI XI ROBOTIC MONOPOLAR SCISSOR COVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 9146374
• MDR Text Key: 161192307
• Report Number: MW5090166
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR