MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI PROGRASP; SYSTEM, SURGICAL, COMPUTER CONTROLLED

Model Number XI

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  malfunction  

Event Description

A prograsp was stuck in the robotic arm during a cholecystectomy case due to a non-recoverable fault.The instrument was rendered nonusable after the fault.There were 6/10 lives remaining on the instrument.Fda safety report id# (b)(4).

• Brand Name: DAVINCI PROGRASP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 9353992
• MDR Text Key: 167555758
• Report Number: MW5091208
• 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: 11/19/2019

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 Model Number: XI
• Device Catalogue Number: 470093
• Device Lot Number: N10190604 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• 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