FDA Adverse Event Injury Summary report: N

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

MDR report key: 8903760 · Received August 16, 2019

Report

Report Number: 1222780-2019-00187
Event Type: Injury
Date Received: August 16, 2019
Date of Event: July 15, 2019
Report Date: July 29, 2019
Manufacturer: HOLOGIC, INC
Product Code: MNB
PMA / PMN Number: P010013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. 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. 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 OR THE RADIO FREQUENCY CONTROLLER AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. INTERNAL REFERENCE #: (B)(4).

Description of Event or Problem · 1

THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT # 1222780-2019-00189. IT WAS REPORTED THAT DURING A FIBROID REMOVAL PROCEDURE, PRE ENDOMETRIAL ABLATION, THE FLUID DEFICIT BEGAN TO RISE. AFTER THE FIBROID WAS REMOVED, THE PHYSICIAN PROCEEDED TO THE ABLATION PROCEDURE. THE DEVICE PASSED CAVITY INTEGRITY ASSESSMENT AND THE ABLATION WAS CARRIED OUT. POST ABLATION LAPAROSCOPY REVEALED A UTERINE PERFORATION AND MINOR BOWEL BURNS. NO ADDITIONAL DETAILS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
695665	NOVASURE IMPEDANCE CONTROLLED EA SYSTEM	UTERINE ABLATION DEVICE	MNB	HOLOGIC, INC	NS2007	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other