MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI V. SEALER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number XI

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

Two one time use robotic instruments malfunctioned during the same case.1- a vessel sealer signaled a message reading "blade may be exposed".The second is a sureform 60 stapler that would not engage when inserted into the robotic arm.The rep was called and she informed them to open new instruments to complete the case.Fda safety report id # (b)(4).

• Brand Name: DA VINCI V. SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 12814134
• MDR Text Key: 280935449
• Report Number: MW5105305
• 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: 11/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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: 480422
• Device Lot Number: L480422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1