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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SURESOUND UTERINE SOUNDING DEVICE

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HOLOGIC, INC. SURESOUND UTERINE SOUNDING DEVICE Back to Search Results
Catalog Number SOUND12-923001-01
Device Problem Hole In Material (1293)
Patient Problem No Information (3190)
Event Date 05/16/2017
Event Type  Injury  
Manufacturer Narrative
The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed. 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 # 1222780-2017-00146. It was reported a physician preformed an uneventful novasure endometrial ablation on (b)(6) 2017 and received an unsuccessful cavity integrity assessment (cia) test. Then the physician performed a post ablation hysteroscopy which revealed "two small holes. " no intervention was required and the patient was discharged home. Dilatation (not hologic device) was performed 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 DeviceUTERINE SOUNDING DEVICE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
sidra piracha
250 campus drive
marlborough, MA 01752
5082638884
MDR Report Key6644727
MDR Text Key77697498
Report Number1222780-2017-00149
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 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSOUND12-923001-01
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 Received05/16/2017
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 Initial

Patient Treatment Data
Date Received: 06/15/2017 Patient Sequence Number: 1
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