MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI MONOPOLAR CURVED SCISSORS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number DA VINCI XI

Device Problems Failure to Cut (2587); Physical Resistance/Sticking (4012)

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

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Sticking and not cutting well.Fda safety report id# (b)(4).

• Brand Name: DA VINCI MONOPOLAR CURVED SCISSORS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 10894297
• MDR Text Key: 218205121
• Report Number: MW5098040
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470179 VER19
• Device Lot Number: N12200727 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes
• 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