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

Model Number	NS2000US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that on december 4th, a physician performed a myosure procedure first on a patient, then attempted to perform a uterine ablation using a novasure device, but the cavity initial assessment alarm went off alerting of loss of pressure, he changed the disposable an obtained the same alarm prompting the physician to perform a hysteroscopy observing a perforation on the uterus.He aborted the novasure procedure without making any ablation.No other information available.

• Brand Name: NOVASURE SURESOUND
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11099639
• Report Number: 1222780-2020-00187
• Device Sequence Number: 3283445
• Product Code: MNB
• UDI-Device Identifier: 25420045501147
• UDI-Public: (01)25420045501147(10)20A09RH(17)210809
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

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: 08/09/2021
• Device Model Number: NS2000US
• Device Catalogue Number: NS2000US
• Device Lot Number: 20A09RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention