NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013

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 2020-02-26 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.

Event Text Entries

[181489533] The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications.
Patient Sequence No: 1, Text Type: N, H10


[181489534] It was reported that during the procedure, a uterine perforation was suspected as the device would not pass cavity integrity assessment. A perforation was confirmed via laparoscopy. It is unknown if the perforation was caused by a non-hologic dilator or the endometrial ablation device. Patient was reportedly doing well post procedure and discharged to home.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00039
MDR Report Key9756602
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-26
Date of Report2020-02-05
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Device Manufacturer Date2019-10-10
Date Added to Maude2020-02-26
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 Received2020-02-26
Returned To Mfg2020-03-10
Model NumberNS2013
Catalog NumberNS2013
Lot Number19K10RK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-26

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