MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VULCAN EFLEX ABLATOR PROBE WITH INTEGRATED CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 72200683

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

Coag setting on vulcan flex ablator did not work.Attempted to up setting and turn of and back on machine.Replaced device and new device with machine worked.

• Brand Name: VULCAN EFLEX ABLATOR PROBE WITH INTEGRATED CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11893291
• MDR Text Key: 252965892
• Report Number: 11893291
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2021

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 Model Number: 72200683
• Device Catalogue Number: 72200683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Weight: 73