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

Model Number XI

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

Robotic instrument, mega suture cut needle driver is dull after 5/15 uses and is not cutting suture; 10 lives remain on this instrument. I will return to intuitive for a reimbursement for remaining lives. Fda safety report id# (b)(4).

• Brand Name: DA VINCI MEGA SUTURECUT NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 13118125
• MDR Text Key: 283094093
• Report Number: MW5106363
• 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

• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: XI
• Device Catalogue Number: 471309
• Device Lot Number: K10210329 0183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No