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

Model Number	NS2007
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during the procedure, "the device was flashing check array' and we couldn't get past it.We pulled a second device and that one worked just fine.We were not able to complete the procedure though due to uterine perforation." no additional details available.
Additional Manufacturer Narrative
The returned device was received and tested.The device passed bubble test, cia and array position light.Ablation test failed resulting in a system fault error.Due to this error an eap resistance test was performed resulting in a failed test.To look deeper a visual inspection of the array was performed.A hole in the array was discovered.The hole was most likely torn during the array retraction during the procedure.Also the stowed array looked baggy and it was difficult to close it.For investigation purposes the array was cut open in order to analyze the mechanism.The monofilament looked damaged and broken.This broken monofilament is most likely the contributor to the reported failure mode.Every novasure disposable device is inspected to ensure full functionality prior to final release.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10569205
• Report Number: 1222780-2020-00123
• Device Sequence Number: 2670595
• Product Code: MNB
• UDI-Device Identifier: 35420045501144
• UDI-Public: (01)35420045501144(10)20F03R
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 20F03R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVASURE DEVICE, LOT UNKNOWN; RADIO FREQUENCY CONTROLLER, SN UNKNOWN; NOVASURE DEVICE, LOT UNKNOWN; RADIO FREQUENCY CONTROLLER, SN UNKNOWN