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

Catalog Number 470309

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

Mega suture cut needle drivers were not sharp intraoperatively.Had only been processed 7 times and had lives left.Fda safety report id# (b)(4).

• Brand Name: INTUITIVE MEGA SUTURE CUT NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA
• MDR Report Key: 12985246
• MDR Text Key: 282266128
• Report Number: MW5105980
• 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: 12/08/2021

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 Catalogue Number: 470309
• Device Lot Number: N10200302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1