FDA Adverse Event Injury Summary report: N

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

MDR report key: 3161573 · Received May 6, 2013

Report

Report Number: 1222780-2013-00100
Event Type: Injury
Date Received: May 6, 2013
Date of Event: April 11, 2013
Report Date: May 7, 2013
Manufacturer: HOLOGIC
Product Code: MNB
PMA / PMN Number: P010013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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 IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW AND STERILE LOT REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A NOVASURE ENDOMETRIAL ABLATION WAS DONE ON (B)(6) 2011. A POST HYSTEROSCOPY REVEALED THE UTERUS WAS "WELL CAUTERIZED THROUGHOUT." THE FOLLOWING DAY, (B)(6) 2013, THE PATIENT CALLED THE PHYSICIAN REPORTING A "FEVER OF 101 DEGREES [FAHRENHEIT] AND THE SHAKES." THE PATIENT WAS TREATED WITH AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM). SHE WAS NOT ADMITTED AND NO CULTURES WERE DONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
196725	NOVASURE IMPEDANCE CONTROLLED EA SYSTEM		MNB	HOLOGIC	NS2000	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other\| R	RADIO FREQUENCY CONTROLLER: SERIAL #UNK