NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

Report

Report Number: 1222780-2013-00091
Event Type: Injury
Date Received: May 17, 2013
Date of Event: April 19, 2013
Report Date: April 19, 2013
Manufacturer: HOLOGIC
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 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 WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. REFERENCE INTERNAL COMPLAINT (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION, THE PHYSICIAN PERFORMED A LAPAROSCOPY AND TUBAL LIGATION. THE NOVASURE PROCEDURE WAS COMPLETED, BUT DUE TO DISTENTION LOSS, THE PHYSICIAN PERFORMED A LAPAROSCOPY AND VISUALIZED A ''PERFORATION AT THE CENTER FUNDUS LINE AND FLUID NEAR THE PELVIS. NO THERMAL INJURY TO THE BOWEL NOTED." THE PHYSICIAN CAUTERIZED THE PERFORATION AND REQUESTED THE PT REMAINS FOR ONE NIGHT AT THE FACILITY OBSERVATION. ON (B)(6) 2013, IT WAS REPORTED BY THE PHYSICIAN THE PT WAS ADMITTED OVERNIGHT FOLLOWING THE PROCEDURE, BUT SHE CHECKED HERSELF OUT (NO PHYSICIAN DISCHARGE) THE NEXT DAY, (B)(6) 2013. THE PHYSICIAN HAS NOT SEEN THE PT FOR F/U AND THE PT HAS NOT CONTACTED THE OFFICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
218957	NOVASURE IMPEDANCE CONTROLLED EA SYSTEM		MNB	HOLOGIC	NS2000	UNK

Patients

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