MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLEX ULTRA PTR WITH INTEGRATED CABLE CLOSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EICA4835-01

Device Problem Activation Failure (3270)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

Cable was plugged in and the entire probe would not light up or work.

• Brand Name: REFLEX ULTRA PTR WITH INTEGRATED CABLE CLOSE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 17332000
• MDR Text Key: 319117882
• Report Number: 17332000
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EICA4835-01
• Device Catalogue Number: EICA4835-01
• Device Lot Number: 2091251
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1