MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number CAGEN1

Device Problems Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during ablation procedure, the unit powered up fine.The first antenna was attached, no alarm/alert showing on the generator screen.Zero¿s were showing in the time and power fields.This indicates the antenna and reusable cable are connected and recognized.They set the relevant time and power.The customer pressed the ¿start¿ button but nothing happened.They then swapped for a different antenna, just in case the antenna was the issue.However, the exact same problem occurred.They shut down the system completely and waited for several minutes and powered back on.However, start button would still not activate.Procedure had to be stopped and patient will need to be booked back in for treatment on a different date.There was no patient injury.

• Brand Name: EMPRINT
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 11752365
• MDR Text Key: 248173066
• Report Number: 3004962788-2021-00036
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 10884521190771
• UDI-Public: 10884521190771
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAGEN1
• Device Catalogue Number: CAGEN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1