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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 CA20L1
Medical Device Problem Code Device Alarm System (1012)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/28/2019
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 reporter, during microwave ablation, when the control unit started after selecting power and duration time, reflected power trip alarm appeared on the system.Reset the system, reconnect the cable and stopped the system for ten minutes but same alarm appeared on the system.The surgeon rescheduled the procedure.
 
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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 Key8527302
Report Number3006451981-2019-00066
Device Sequence Number1884347
Product Code NEY
UDI-Device Identifier10884521189546
UDI-Public10884521189546
Combination Product (Y/N)N
Initial Reporter CountryPK
PMA/510(K) Number
K133821
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/18/2019
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 Date04/10/2019
Device Model NumberCA20L1
Device Catalogue NumberCA20L1
Device Lot NumberS8DG010LX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/28/2019
Initial Report FDA Received Date04/18/2019
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 Other;
Patient Age58 YR
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