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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 CA15L1
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem 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.
 
Additional 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.
 
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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 Key8561885
Report Number3006451981-2019-00070
Device Sequence Number11172403
Product Code NEY
UDI-Device Identifier10884521189539
UDI-Public10884521189539
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K133821
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 05/23/2019
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 Expiration Date10/16/2020
Device Model NumberCA15L1
Device Catalogue NumberCA15L1
Device Lot NumberS8KG010X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/09/2019
Supplement Date Received by Manufacturer04/09/2019
Initial Report FDA Received Date04/29/2019
Supplement Report FDA Received Date05/23/2019
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;
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