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

Model Number	CA15L1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during ablation procedure, the device bent as it passed through the patient's costal cartilage.Procedure was aborted and rescheduled.Patient had completed treatment from rescheduled and completed surgery.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found that part of the outer antenna shaft was broken.All parts were still attached to the device.The reported condition was confirmed.The investigation found the shaft of the antenna was broken.This break is consistent with the user exceeding the shaft bend radius limit.The antenna would not activate due to the broken shaft.The investigation identified the root cause of the reported event to be user error.The instructions for use (ifu) states, do not apply excessive lateral or rotational force during insertion or extraction of the antenna.Doing so may lead to breakage of the antenna and injury to the patient or user.Users should not touch the antenna radiating section at any time during the application of power.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8288498
• Report Number: 3006451981-2019-00021
• Device Sequence Number: 2701378
• Product Code: NEY
• UDI-Device Identifier: 10884521725942
• UDI-Public: 10884521725942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S8EG013PCX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 70