EMPRINT CA20L2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-30 for EMPRINT CA20L2 manufactured by Covidien Medical Products.

Event Text Entries

[180041310] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[180041311] According to the reporter, during a procedure, at first, the saline was found to be flowed normally, but the flow gradually decreased and the liquid stopped flowing. After that, high temperature error occurred. The pump was cycling. The procedure was completed with another device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006451981-2020-00015
MDR Report Key9648014
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-01-30
Date of Report2020-03-20
Date of Event2020-01-16
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-09-04
Date Added to Maude2020-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1COVIDIEN MEDICAL PRODUCTS
Manufacturer StreetBUILDING 10- NO 789 PUXING ROA
Manufacturer CitySHANGHAI 201114
Manufacturer CountryCN
Manufacturer Postal Code201114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMPRINT
Generic NameSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Product CodeNEY
Date Received2020-01-30
Returned To Mfg2020-02-21
Model NumberCA20L2
Catalog NumberCA20L2
Lot NumberS9JG008X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MEDICAL PRODUCTS
Manufacturer AddressBUILDING 10- NO 789 PUXING ROA SHANGHAI 201114 CN 201114


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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