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

Model Number XI

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Description

The tip of the da vinci xi irrigator bent while in use and was not able to be removed from the trocar while case was in progress.This occurred at the end of the case.The surgeon scrubbed back in and had to totally remove the trocar from the pt's abdomen.Since it was the end of the case, all instruments and trocars were removed and closure began.No harm was done to the pt.Fda safety report id# (b)(4).

• Brand Name: DA VINCI SUCTION IRRIGATOR
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale 84086
• MDR Report Key: 13118701
• MDR Text Key: 283175923
• Report Number: MW5106384
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XI
• Device Catalogue Number: 480299
• Device Lot Number: M10210720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1