MAUDE Adverse Event Report: HOLOGIC, INC NOVASURE IMPEDANCE CONTROLLED EA SYSTEM; UTERINE ABLATION DEVICE

Model Number NS2013

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

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.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.

Event Description

It was reported that during the procedure the physician completed an ablation and then visualized the patient cavity.Physician states he saw no ablation at the fundus region.Physician then re-inserted the same device to perform a "second burn" which also did not accomplish the appearance of a fundal burn.The physician "readily acknowledged that he knows that double burning is not indicated." physician then opened a second device to re-ablate.Physician did not indicate if the second device provided the burn he was seeking, but instead stated that upon removal and re-visualization of the cavity with hysteroscope, he saw 'gold colored mesh' left behind in the uterus.No known injury to patient.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Type of Device: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9539514
• MDR Text Key: 175056725
• Report Number: 1222780-2020-00002
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 35420045501113
• UDI-Public: (01)35420045501113(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: NS2013
• Device Catalogue Number: NS2013
• Device Lot Number: 19J05RM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1