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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 Codes Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/23/2020
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 a procedure, the generator stopped working and the antenna bent.The procedure was aborted.
 
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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 Key10261011
Report Number3006451981-2020-00102
Device Sequence Number19796830
Product Code NEY
UDI-Device Identifier10884521189539
UDI-Public10884521189539
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K133821
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/10/2020
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 Date04/12/2022
Device Model NumberCA15L1
Device Catalogue NumberCA15L1
Device Lot NumberS7JG037LCX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2020
Initial Report FDA Received Date07/10/2020
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 Other;
Patient Age64 YR
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