MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS UNKNOWN EMPRINT ANTENNA; Electrosurgical, cutting & coagulation & accessories

Model Number UNKNOWN EMPRINT ANTENNA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Stenosis (2263)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown cool ti, unknown cool tip elecrtrode (lot#unknown); unk emprint ant, unknown emprint antenna (lot#unknown); unknown cool ti, unknown cool tip elecrtrode (lot#unknown); unk emprint ant, unknown emprint antenna (lot#unknown); unknown cool ti, unknown cool tip elecrtrode (lot#unknown); title: safety and efficacy of rfa versus mwa for t1a renal cell carcinoma: a propensity score analysis source: https://doi.Org/10.1007/s00330-022-09110-w european radiology (2023) 33:1040¿1049 date: 6 september 2022.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 Description

According to the literature, a retrospective study between 2004 to 2018 was performed to compare safety and efficacy of radiofrequency ablation and microwave ablation for the treatment of renal cell carcinoma.There were 87 masses treated with radiofrequency ablation using cool tip or a competitor device.There were 101 masses treated with microwave ablation using emprint, evident or a competitor device.In the microwave ablation group, there was one major complication of stenosis resulting in kidney failure.

• Brand Name: UNKNOWN EMPRINT ANTENNA
• Type of Device: Electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16600391
• MDR Text Key: 311953845
• Report Number: 3006451981-2023-00040
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EMPRINT ANTENNA
• Device Catalogue Number: UNKNOWN EMPRINT ANTENNA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male