FDA Adverse Event Injury Summary report: N

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

MDR report key: 3853477 · Received May 28, 2014

Report

Report Number: 1222780-2014-00081
Event Type: Injury
Date Received: May 28, 2014
Date of Event: April 28, 2014
Report Date: April 28, 2014
Manufacturer: HOLOGIC
Product Code: MNB
PMA / PMN Number: P010013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. (B)(4).

Description of Event or Problem · 1

NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT # 1222780-2014-00080. IT WAS REPORTED THAT A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014 AND RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND NOTED A UTERINE PERFORATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AND A PHYSICIAN "PUT A STITCH IN THE 5MM PERFORATION". THE PATIENT WAS ADMITTED INTO THE HOSPITAL AS SHE OPTED TO HAVE A HYSTERECTOMY. THE HYSTERECTOMY WAS COMPLETED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2014. A HYSTEROSCOPY AND DILATION (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENTS MAY HAVE BEEN THE CAUSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
313049	NOVASURE IMPEDANCE CONTROLLED EA SYSTEM	UTERINE ABLATION DEVICE	MNB	HOLOGIC	NS2000	13F06RA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization\| R	SURESOUND: LOT NUMBER UNK\| RADIO FREQUENCY CONTROLLER: SN UNK