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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE SURESOUND ENDOMETRIAL ABLATION SYSTEM SOUND, UTERINE

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HOLOGIC, INC. NOVASURE SURESOUND ENDOMETRIAL ABLATION SYSTEM SOUND, UTERINE Back to Search Results
Catalog Number NS2007US
Device Problem Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Event Description
During hysterectomy, device did not fire when pedal was activated. Attempted three more times, unsuccessfully. New device was then opened and used. No harm to pt. Fda safety report id# (b)(4).
 
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Brand NameNOVASURE SURESOUND ENDOMETRIAL ABLATION SYSTEM
Type of DeviceSOUND, UTERINE
Manufacturer (Section D)
HOLOGIC, INC.
marlborough MA 01752
MDR Report Key8730838
MDR Text Key149261673
Report NumberMW5087574
Device Sequence Number1
Product Code HHM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNS2007US
Device Lot Number(01)15420045501133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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