• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE ADVANCED SURESOUND SOUND, UTERINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLOGIC, INC. NOVASURE ADVANCED SURESOUND SOUND, UTERINE Back to Search Results
Catalog Number NS2013KITUS
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
Event Type  malfunction  
Event Description
Novasure would not pass the cavity assessment, it kept failing. A second device was opened and functioned as expected. Manufacturer response for impedence controlled endometrial ablation disposable, novasure advanced suresound (per site reporter) : manufacturer provided rga# and product return packaging.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVASURE ADVANCED SURESOUND
Type of DeviceSOUND, UTERINE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key7586344
MDR Text Key110648710
Report Number7586344
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2020
Device Catalogue NumberNS2013KITUS
Device Lot Number18A09RD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-