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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SURESOUND SOUNDING INSTRUMENT

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HOLOGIC, INC SURESOUND SOUNDING INSTRUMENT Back to Search Results
Catalog Number SOUND12
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Perforation (2001)
Event Date 03/14/2016
Event Type  Injury  
Manufacturer Narrative
Lot number of the suresound not provided by the complainant, therefore the expiration date is not known. The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed. Mfg date: lot number of the suresound not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant. According to the instructions for use (ifu) adverse events: potential adverse events include, but are not limited to perforation of the uterine wall. (b)(4).
 
Event Description
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2016-00094. It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016 and the physician received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices. The physician "viewed a perforation in the center of the uterus". A laparoscopy was performed and the physician cauterized the perforation. The procedure was aborted. It is unknown if the patient was discharged home. We have been unable to obtain additional information surrounding this event. Dilatation performed (not a hologic device) prior to the attempted ablation. It is not known when this perforation occurred or what instrument may have been the cause.
 
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Brand NameSURESOUND
Type of DeviceSOUNDING INSTRUMENT
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 01752
5082638859
MDR Report Key5574632
MDR Text Key42606149
Report Number1222780-2016-00095
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
Report Date 03/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSOUND12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/13/2016 Patient Sequence Number: 1
Treatment
RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK
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