MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. CADIERE FORCEPS 8MM DA VINCI XI SURGICAL SYSTEMS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 471049

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Description

A cadiere forceps 8mm device for da vinci robot was placed on robot arm and inserted into pt.Upon rotating device in view of the camera, a small piece of rigid plastic or metal was seen at the hinge of the device.Device was immediately removed and replaced as this piece appeared to be a defect in the device.Fda safety report id# (b)(4).

• Brand Name: CADIERE FORCEPS 8MM DA VINCI XI SURGICAL SYSTEMS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 14105108
• MDR Text Key: 289317183
• Report Number: MW5108958
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 471049
• Device Lot Number: N10201103 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1