MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC, INC.; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CF7-7-60

Device Problems Break (1069); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Nurse plugged in endovenous catheter into ablation monitor and catheter would not work.Unit kept firing an error of "device broken".Obtained different catheter from the same lot and did not experience further issues.

• Brand Name: MEDTRONIC, INC.
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC, INC.; 2300 berkshire ln n; plymouth MN 55441
• MDR Report Key: 17208299
• MDR Text Key: 317935220
• Report Number: 17208299
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF7-7-60
• Device Lot Number: 221780236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1