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

Model Number XI

Device Problem Entrapment of Device (1212)

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

Event Type  malfunction  

Event Description

A single use suction irrigator was stuck in the reducer which is a plastic piece that fits into a 12mm da vinci trocar enabling that 12mm trocar to become a size 8mm.Because we were already in the middle of the case, we had to remove the insert and open a whole new insert and new instrument.I will return it to intuitive to see if i can get a reimbursement.Fda safety report id # (b)(4).

• Brand Name: DA VINCI / ROBOTIC SUCTION IRRIGATOR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11435204
• MDR Text Key: 238872724
• Report Number: MW5099826
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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: #480299
• Device Lot Number: M10201109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1