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

Model Number XI

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

This xi robotic instrument large suturecut needle driver is not grasping.Remaining lives 14/15 on this instrument.I will return to intuitive for reimbursement.Fda safety report id # (b)(4).

• Brand Name: DA VINCI LARGE SUTURECUT NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 13087456
• MDR Text Key: 282898178
• Report Number: MW5106268
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 471296 VER 07
• Device Lot Number: N11211011 0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1