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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 Codes Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Visual inspection found the ceramic tip is missing from the device.The tip was not returned.The reported condition was confirmed.The investigation found the ceramic tip was missing on the returned device.The investigation identified the cause of the additional failure to be a design issue.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the device was returned without a complaint information.Initial evaluation of the incident device found that the ceramic tip is missing from the device.The tip was not returned.
 
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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 Key10029723
Report Number3006451981-2020-00072
Device Sequence Number3881796
Product Code NEY
UDI-Device Identifier10884521706583
UDI-Public10884521706583
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K163105
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/06/2020
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 Model NumberCA15L2
Device Catalogue NumberCA15L2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/14/2020
Initial Report FDA Received Date05/06/2020
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;
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