FDA.reportPublic FDA data

MAUDE MDR 9599302

MDR report key
9599302
Report number
1222780-2020-00010
Event key
0
Event type
3
Date of event
2019-12-27
Date received
2020-01-16
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 01752 US
Phone
508-508-5082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOVASURE IMPEDANCE CONTROLLED EA SYSTEMUTERINE ABLATION DEVICEHOLOGIC, INCMNBNS2007NS200719G29RR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1601. L; 2. O; 3. 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 AFTER SMALL FIBROIDS WERE REMOVED FROM THE PATIENT UTERUS, THE ABLATION BEGAN. 36 SECONDS INTO THE ABLATION CYCLE, THE PATIENT HAD A "MOMENTARY FLATLINE." THE PHYSICIAN PAUSED THE ABLATION. ANESTHESIA THEN INFORMED THE PHYSICIAN THAT THE PATIENT WAS STABLE AGAIN AND IT WAS OKAY TO RESUME PROCEDURE. AFTER RESUMING THE PROCEDURE, THE PATIENT HAD ANOTHER SHORT REACTION THAT LASTED A FEW SECONDS. AGAIN, THE PHYSICIAN PAUSED THE ABLATION CYCLE UNTIL ANESTHESIA WAS ABLE TO STABILIZE THE PATIENT. THE ANESTHESIOLOGIST GAVE THE "GO AHEAD" TO RESUME PROCEDURE ONE MORE TIME. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE AT 101 SECONDS, WITH NO FURTHER COMPLICATIONS. PATIENT'S HEART RATE AND ALL OXYGEN SATURATION WERE STABLE AT THE END OF THE CASE. NO FURTHER INFORMATION WAS PROVIDED.