MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	CAGEN1
Medical Device Problem Codes	Device Alarm System (1012); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a procedure, after a generator shut down of 1h, it had been restarted for another patient.Same general alarm was present from the start this time, but only on the 100w setting.No alarm on 75w setting, so the procedure had been started, but aborted because the physician had no sign of treatment on per op medical imaging (ultrasound and ct scan control), so it seems 75w did not work despite lack of alarm (2 antennas had been used during this procedure).The patient had to be rescheduled and treated.
Additional Manufacturer Narrative
D10: concomitant products: ca15l2, ca15l2 15cm rein percutaneous antenna x1, (lot #s23lg005) ca20l2, a20l2 20cm rein percutaneous antenna x1, (lot #s23ag003) ca190rc1, ca190rc1 ablation reusable cable x1, (sn: (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EMPRINT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19110633
• Report Number: 3004962788-2024-00027
• Device Sequence Number: 12851898
• Product Code: GEI
• UDI-Device Identifier: 10884521190771
• UDI-Public: 10884521190771
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAGEN1
• Device Catalogue Number: CAGEN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/15/2024
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male