MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI MEGA SUTURE CUT NEEDLE DRIVER; SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT

Model Number XI

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Event Description

On side of the tips of this da vinci mega suture cut needle driver (xi) would not close properly during the case.A new instrument was opened and used to complete the case.Fda safety report id # (b)(4).

• Brand Name: DA VINCI MEGA SUTURE CUT NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 9653226
• MDR Text Key: 177566717
• Report Number: MW5092636
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• 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: 01/28/2020

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: XI
• Device Catalogue Number: 470309
• Device Lot Number: N12190826 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2020
• 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