NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2007 manufactured by Hologic, Inc.

Event Text Entries

[182701676] Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10


[182701677] It was reported that during the procedure, the device would not pass cavity integrity assessment. A uterine perforation was confirmed. It is unknown if the perforation occurred at sounding or upon ablation device being inserted. Procedure was aborted. No additional details available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00050
MDR Report Key9809065
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-09
Date of Report2020-02-19
Date of Event2020-02-18
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-09
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 ContactKELSEA LYVER
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH, MA
Manufacturer CountryUS
Manufacturer Phone2636130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVASURE IMPEDANCE CONTROLLED EA SYSTEM
Generic NameUTERINE ABLATION DEVICE
Product CodeMNB
Date Received2020-03-09
Model NumberNS2007
Catalog NumberNS2007
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-09

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