MAUDE Adverse Event Report: INTUITIVE SURGICAL VESSEL SEALER

Catalog Number 410322

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2017

Event Type  malfunction  

Event Description

Vessel sealer was plugged in and introduced to the robotic arm.The robot gave an alert so it was removed and reintroduced.It alarmed again and said vessel sealer malfunctioned.The vessel sealer was removed and replaced with a new one which worked properly.The sealer did not reach the patient.

• Brand Name: VESSEL SEALER
• Type of Device: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 6673130
• MDR Text Key: 78693813
• Report Number: MW5070674
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410322
• Device Lot Number: M11161114
• 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