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

Model Number	NS2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vaso-Vagal Response (2661)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).
Event or Problem Description
It was reported on medwatch (b)(4) by the user facility: "an incident with a female of (b)(6) in (b)(6) 2017.Patient had heavy vaginal bleeping, ckd stage iii atrophic kidney.Patient suffered bradycardia at onset of ablation, likely vagal response to stimulation.Heartrate noted to be 17 bpm, sa 02 99%, etco2 _ 20 ivp atropine had been administered and epinephrine 200 mg given.Pulse check performed with no appreciable femoral pulse per nursing, therefore chest compressions were started.Laryngeal mask airway removed, endotracheal tube placed with + etco2 confirmed.Compressions occurred for - 30 seconds, stopped after pulse, etco2 increased to normal hr and rhythm confirmed.Patient remained hemodynamically stable and was extubated after displaying appropriate respiratory effort and neuromuscular recovery.Ekg performed in post-anesthesia care unit displaying normal sinus rhythm.Possible laryngospasm, however no loss of etco2 or desaturation noted".We have been unable to obtain additional information surrounding this event.

• 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: 7135548
• Report Number: 1222780-2017-00289
• Device Sequence Number: 1260614
• Product Code: MNB
• UDI-Device Identifier: 15420045501133
• UDI-Public: (01)15420045501133(10)17F14RD(01)35420045501137(10)17F14RD
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: Physician
• Device Expiration Date: 07/14/2018
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 17F14RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: RADIO FREQUENCY CONTROLLER: CSP6520
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR