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

Model Number 410322

Device Problems Failure to Sense (1559); Device Displays Incorrect Message (2591)

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

Event Date 08/30/2019

Event Type  malfunction  

Event Description

The first intuitive surgical, davinci si, vessel sealer was not acknowledged by the generator.The second vessel sealer produced a blade exposed warning fault; (2 devices).Fda safety report id# (b)(4).

• Brand Name: ENDOWRIST ONE VESSEL SEALER DAVINCI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL ; sunnyvale CA 94086
• MDR Report Key: 8965138
• MDR Text Key: 158638255
• Report Number: MW5089563
• 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: 09/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M10180824
• 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: 52 YR