MAUDE Adverse Event Report: SURESOUND; UTERINE SOUNDING DEVICE

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.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5320512
• MDR Text Key: 34179203
• Report Number: 1222780-2015-00239
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: SOUND12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• 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 Number: 1
• Treatment: NOVASURE DISPOSABLE DEVICE-15H17RC
• Patient Outcome(s): Other