MAUDE Adverse Event Report: INTUITIVE SURGICAL VESSEL SEALER

Model Number 480322

Device Problem Device Stops Intermittently (1599)

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

Event Date 08/23/2017

Event Type  malfunction  

Event Description

Robotic vessel sealer was not working in a consistent manner.It was only working intermittently.

• Brand Name: VESSEL SEALER
• Type of Device: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 6871927
• MDR Text Key: 86589337
• Report Number: MW5072174
• 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: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 480322
• Device Lot Number: M10170612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2017
• 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: 83 YR
• Patient Weight: 100