MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI; SYSTEM, SURGICAL ,COMPUTER CONTROLLED INSTRUMENT

Model Number 410322

Device Problems Material Protrusion/Extrusion (2979); Output Problem (3005)

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

Event Date 10/01/2018

Event Type  malfunction  

Event Description

While surgeon was using vessel sealer.A recoverable fault occurred stating blade was exposed.Instrument removed from patient and packaged to bring to acm.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM, SURGICAL ,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7951125
• MDR Text Key: 123261035
• Report Number: 7951125
• Device Sequence Number: 0
• Product Code: NAY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Lot Number: M10180410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1