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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
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COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES Back to Search Results
Model Number CA15L2
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event 12/30/2019
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, the antenna was completely reinserted a total of two times, repositioned twice per insertion, and one additional minor adjustment but the tip of the probe broke while in the patient body after providing 5 ablations.The physician had decided to leave the tip in the patient body with patient's consent.Computed tomography (ct) scan located the tip within the liver.
 
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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 Key9558482
Report Number3006451981-2020-00005
Device Sequence Number2283424
Product Code NEY
UDI-Device Identifier10884521706583
UDI-Public10884521706583
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K163105
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/07/2020
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 Expiration Date09/28/2021
Device Model NumberCA15L2
Device Catalogue NumberCA15L2
Device Lot NumberS9JG027X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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