MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number CA15L1

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during ablation, during the first insertion of antenna, it was broken.Medical intervention done to remove the antenna.Surgery extended for more than 30 minutes.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMPRINT
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8561885
• MDR Text Key: 143453505
• Report Number: 3006451981-2019-00070
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 10884521189539
• UDI-Public: 10884521189539
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S8KG010X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Date Device Manufactured: 10/17/2018
• 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): Required Intervention