MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	2000
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Device was returned: a visual inspection was performed and the device appeared to retain an overall acceptable integrity (including the sheath).No missing parts or missing components were detected.A functional test was performed, including cia, epa test, and ablation, and the device performed as expected.Hence the complaint cannot be confirmed.
Event or Problem Description
It was reported that a patient received a novasure procedure (b)(6) and that the procedure went well but after the procedure the md observed a piece of the array inside the uterus and removed it.The device was examined and it appears the metal came from it.No patient injury was reported.The device was returned and analized.Visual inspection was performed and the device appeared to reatin an overall acceptable integrity incluiding the sheath.No missing parts or missing componentes were detected.A functional test was performed including cia, epa test and ablation and the device performed as expected.Hence the complaint cannot be confirmed.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 14341586
• Report Number: 1222780-2022-00125
• Device Sequence Number: 5237229
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(10)21G28RF(17)230218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: 2000
• Device Catalogue Number: NS2000US
• Device Lot Number: 21G28RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female