MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI SUCTION IRRIGATOR ; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number 480299

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981); Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

The end of the robotic xi suction irrigator (sleeve) got twisted and jammed.The instrument was unable to be removed from the trocar.The surgeon opted to remove the whole trocar and a new set of both an irrigation and da vinci trocar were opened and used to complete the case.Fda safety report id# (b)(4).

• Brand Name: DA VINCI XI SUCTION IRRIGATOR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 8759515
• MDR Text Key: 150164585
• Report Number: MW5087828
• 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: 07/01/2019

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 Catalogue Number: 480299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• 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