MAUDE Adverse Event Report: INTUITIVE SURGICAL INC DAVINCI LARGE SUTURE CUT NEEDLE DRIVER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number DAVINCI XI

Device Problem Failure to Cut (2587)

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

Event Date 08/20/2020

Event Type  malfunction  

Event Description

Instrument failed to cut suture.Fda safety report id# (b)(4).

• Brand Name: DAVINCI LARGE SUTURE CUT NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC; sunnyvale CA 94086
• MDR Report Key: 10613068
• MDR Text Key: 209575673
• Report Number: MW5096987
• 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: 09/29/2020

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: DAVINCI XI
• Device Catalogue Number: 470296
• Device Lot Number: N10191119 0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• 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