MAUDE Adverse Event Report: INTUITIVE INTUITIVE VESSEL SEALER

Lot Number M10160804

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

The vessel sealer was placed in arm #1 at the beginning of the case and it failed to self check.The instrument was removed and replaced with a new vessel sealer.No harm to patient occurred.Diagnosis or reason for use: fibroids.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.

• Brand Name: INTUITIVE VESSEL SEALER
• Type of Device: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE; sunnyvale CA
• MDR Report Key: 6410633
• MDR Text Key: 70252585
• Report Number: MW5068501
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: M10160804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• 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: 44 YR