• 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. SURESOUND UTERINE SOUNDING DEVICE

  • 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. SURESOUND UTERINE SOUNDING DEVICE Back to Search Results
Model Number NS2013KIT
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
The device has not yet been 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. Internal complaint reference: (b)(4).
 
Event Description
It was reported that during a novasure endometrial ablation procedure the physician was having trouble measuring the cavity using the suresound device. When the physician removed the device they noticed that three of the prongs were missing. The physician completed the ablation and then scoped the patient and noticed the three progs in the patient's uterus. A dilation and curretage were performed, but the physician did not have graspers and only two of the prongs were able to be removed. "the physician is bringing the patient back asap to have the other one removed which will be at their other facility. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESOUND
Type of DeviceUTERINE SOUNDING DEVICE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key8506510
MDR Text Key141725483
Report Number1222780-2019-00083
Device Sequence Number1
Product Code HHM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/03/2021
Device Model NumberNS2013KIT
Device Catalogue NumberNS2013KIT
Device Lot Number18M03RC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2019 Patient Sequence Number: 1
-
-