MAUDE Adverse Event Report: INTUITIVE SURGICAL OPERATIONS ROBOTIC NEEDLE DRIVER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number N1020130

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

Robotic needle driver broke while in use during a hernia repair.Fda safety report id# (b)(4).

• Brand Name: ROBOTIC NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL OPERATIONS; sunnyvale CA 94086
• MDR Report Key: 12960510
• MDR Text Key: 281989351
• Report Number: MW5105895
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N1020130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1