MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. VINCI XIL PROGRASP; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number N11200817

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

The robotic instrument arm (prograsp forceps) found broken when removed from the patient abdominal/right flank cavity.Fda safety report id# (b)(4).

• Brand Name: VINCI XIL PROGRASP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11663986
• MDR Text Key: 245576984
• Report Number: MW5100760
• Device Sequence Number: 1
• Product Code: NAY
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N11200817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1