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 2020-03-20 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2007 manufactured by Hologic, Inc.

Event Text Entries

[184386688] Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. 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.
Patient Sequence No: 1, Text Type: N, H10


[184386689] It was reported that during the procedure, the physician attempted to pass cavity integrity assessment twice. The physician then utilized vaseline and gauze in an attempt to seal the cervix twice but the device would not pass cavity integrity assesment. The device was removed from the patient and reseated, it then passed assessment and the ablation was completed. After ablation was completed, a laparoscopy was performed to complete a planned salpingectomy. On laparoscopy, two areas of blanching as well as a uterine perforation were found. General surgeon noted a burn to the patient colon. Reportedly, the area of concern was removed and the rectal serosa was oversewn. No additional details available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00060
MDR Report Key9861047
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-02-28
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-11-21
Date Added to Maude2020-03-20
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 Received2020-03-20
Model NumberNS2007
Catalog NumberNS2007
Lot Number19L2RT
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; 2. Required No Informationntervention 2020-03-20

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