MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. ENDOWRIST ONE VESSEL SEALER, DAVINCI VESSEL DEALER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 410322

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/11/2019

Event Type  malfunction  

Event Description

While intuitive surgical da vinci si endowrist one vessel sealer was in use per manufacturer's recommendations, a blade malfunction occurred.Since the vessel sealer would no longer function, it was removed from the field.It was replaced with a "like" device that functioned without issue for the remainder of the procedure.

• Brand Name: ENDOWRIST ONE VESSEL SEALER, DAVINCI VESSEL DEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 8414219
• MDR Text Key: 138691146
• Report Number: MW5084846
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M11181125
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 93 YR