MAUDE Adverse Event Report: HOLOGIC SURESOUND; UTERINE SOUNDING DEVICE

Catalog Number SOUND12-923001-01

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 02/01/2015

Event Type  Injury  

Event Description

This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2014-00031.It was reported that a physician performed a novasure endometrial ablation and received three unsuccessful cavity integrity assessment (cia) tests.The physician suspected a perforation and aborted the procedure.It is unknown if intervention was required.A hysteroscopy and dilatation (not hologic devices) were performed prior to the attempted ablation.It is not known when this perforation occurred or what instrument may have been the cause.

Manufacturer Narrative

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 effects: potential adverse events include, but are not limited to perforation of the uterine wall.Reference internal complaint (b)(4).

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4606272
• MDR Text Key: 5764575
• Report Number: 1222780-2015-00030
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2015

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: Health Professional
• Device Catalogue Number: SOUND12-923001-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/06/2015
• 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: RADIO FREQUENCY CONTROLLER - CSP7320.
• Patient Outcome(s): Other