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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURESOUND; UTERINE SOUNDING DEVICE

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SURESOUND; UTERINE SOUNDING DEVICE Back to Search Results
Catalog Number SOUND12
Device Problem Difficult To Position (1467)
Patient Problem No Code Available (3191)
Event Date 12/02/2015
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.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# 1222780-2014-00240.It was reported that a physician attempted to perform a novasure endometrial ablation on (b)(6) 2015 and was having difficulty opening the electrode array inside the patient.The physician eventually did open the array too far and suspected a perforation.The procedure was aborted.A post hysteroscopy was performed, but there was no visualization, as the physician was unable to hold distension.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 Name
SURESOUND
Type of Device
UTERINE SOUNDING DEVICE
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 01752
5082638859
MDR Report Key5320512
MDR Text Key34179203
Report Number1222780-2015-00239
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 Physician
Type of Report Initial
Report Date 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberSOUND12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2015
Initial Date FDA Received12/22/2015
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 Sequence Number1
Treatment
NOVASURE DISPOSABLE DEVICE-15H17RC
Patient Outcome(s) Other;
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