FDA.reportPublic FDA data

MAUDE MDR 9865786

MDR report key
9865786
Report number
1222780-2020-00063
Event key
0
Event type
3
Date of event
2020-03-02
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KELSEA LYVER
Address
250 CAMPUS DRIVE MARLBOROUGH, MA US
Phone
263-263-2636
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOVASURE IMPEDANCE CONTROLLED EA SYSTEMUTERINE ABLATION DEVICEHOLOGIC, INCMNBNS2013NS201319M06RKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. O; 2. R

Event Narratives#

N

Patient 1

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. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED IDENTIFICATION NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS.

D

Patient 1

IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAVITY WAS VIEWED VIA HYSTEROSCOPE PRIOR TO THE ABLATION. CAVITY WAS INTACT. THE ABLATION DEVICE WAS INSERTED INTO THE PATIENT AND FAILED CAVITY INTEGRITY ASSESSMENT TWO TIMES. THE CAVITY WAS VIEWED AGAIN AND A PERFORATION WAS SEEN. A LAPAROSCOPY WAS PERFORMED WHICH CONFIRMED THE PERFORATION. THE PHYSICIAN "WAS GOING TO ZAP AND TREAT WITH LIGASURE" PER HOLOGIC REPRESENTATIVE PRESENT DURING THE CASE. NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.