MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLEX ULTRA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number EICA4845-01

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

The hand piece would not coblate.Defective hand piece.

• Brand Name: REFLEX ULTRA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11146642
• MDR Text Key: 226042753
• Report Number: 11146642
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EICA4845-01
• 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: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1