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

Model Number XI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

A very small fragment of a vessel sealer extend broke off into the patient.This fragment was visualized with the da vinci robot.The fragment was retrieved and removed.The instrument and the fragment being sent back to intuitive for reimbursement of the instrument.Fda safety report id # (b)(4).

• Brand Name: DA VINCI VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 12532567
• MDR Text Key: 273675220
• Report Number: MW5104203
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: M90210209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• 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