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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGICNOVASURE IMPEDANCE CONTROLLED EA SYSTEM

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HOLOGIC NOVASURE IMPEDANCE CONTROLLED EA SYSTEM   Back to Search Results
Model Number NS2000
Device Problem No Known Device Problem
Event Date 11/27/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

User facility reported that during a novasure endometrial ablation in 2009, the physician "had difficulty inserting the novasure device and several attempts were made prior to the device being successfully inserted into the uterine cavity". Two days post ablation, two days later, the pt was admitted to the hosp with septicemia. The pt "tested positive for infection. "treatment included intravenous (iv) antibiotics: ceftriazone sodium and metronidazole (flagyl). This pt received one dose of cetriazone sodium (iv) just prior to the novasure procedure. The physician noticed "the pt was slow to wake up from the ga [general anesthesia] and complained about being hot and clammy prior to discharge home". During follow-up the following month, it was revealed that the pt was discharged from the hosp two weeks prior and at this time, "the pt is doing well with no obvious ongoing issues".

 
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 lot number of the disposable device. The lot was released meeting all qa specifications. Currently unable to establish a relationship or impact to the reported observation. Sterile lot records were reviewed for this disposable device and were confirmed to be within specified limits. Based on the info obtained to date, no direct correlation can be made between the reported event and the novasure system. According to the instructions for use (ifu) other adverse events: the following adverse event could occur or have been reported in association with the use of the novasure system: infection or sepsis.

 
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Brand NameNOVASURE IMPEDANCE CONTROLLED EA SYSTEM
Manufacturer (Section F)
HOLOGIC
marlborough MA
Manufacturer (Section D)
HOLOGIC
marlborough MA
Manufacturer Contact
craig callahan, mgr
250 campus drive
marlborough , MA 01752
(508) 263 -8859
Device Event Key1615441
MDR Report Key1570209
Event Key1494858
Report Number1222780-2009-00185
Device Sequence Number1
Product CodeMNB
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/14/2010
Device MODEL NumberNS2000
Device Catalogue Number915002-01
Device LOT Number09G14RD
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Device Age5 mo
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/30/2009 Patient Sequence Number: 1
#TreatmentTreatment Date
RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK
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