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

Model Number	CAGENHP
Medical Device Problem Codes	Connection Problem (2900); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant product: ca190rc1 - ca190rc1 ablation reusable cable x1, serial# (b)(6) ca15l2 - ca15l2 15cm rein percutaneous antenna x1, lot# s23cg012 ca20l2 - ca20l2 20cm rein percutaneous antenna x1, lot# s22hg007 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the two antennas has not been detected by the generator, and the "?" alarm ("antenna not identified") remain displayed.Customer stated that it came from the cable because a procedure has been performed successfully previously the same day with the same cable, and after this event the antenna that worked on the previous procedure was not identified anymore as the two others, whereas it was well identified sooner. procedure was cancelled - patient under anesthesia. it is planned to be rescheduled, but the date remains unknown yet.There was no patient injury.
Event or Problem Description
According to the reporter, during a procedure, the two antennas has not been detected by the generator, and the "?" alarm ("antenna not identified") remain displayed.Customer stated that it came from the cable because a procedure has been performed successfully previously the same day with the same cable, and after this event the antenna that worked on the previous procedure was not identified anymore as the two others, whereas it was well identified sooner. procedure was cancelled - patient under anesthesia. it was planned to be re scheduled, but the date remains unknown yet.
Additional Manufacturer Narrative
New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMPRINT HP
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth,mn CO 55441 3299
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth,mn CO 55441 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17869444
• Report Number: 1717344-2023-01238
• Device Sequence Number: 5953856
• Product Code: NEY
• UDI-Device Identifier: 10884521781276
• UDI-Public: 10884521781276
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200796
• 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,Followup
• Report Date (Section B): 10/27/2023

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: CAGENHP
• Device Catalogue Number: CAGENHP
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/27/2023
• Date Device Manufactured: 09/23/2022
• 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 H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown