MAUDE Adverse Event Report: HOLOGIC SURESOUND; UTERINE SOUNDING DEVICE

Catalog Number SOUND12

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Internal Organ Perforation (1987)

Event Date 07/18/2014

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# 1222780-2014-00134.It was reported a physician performed a novasure endometrial ablation on (b)(6) 2014 and received several unsuccessful cavity integrity assessment (cia) tests.The physician suspected a perforation at the "mid fundal area", but could not confirm during the hysteroscopy.The procedure was aborted.No intervention was required and the patient was discharged home.A hysteroscopy, dilatation, and sounding with both a suresound device and metal sound (non hologic device) 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

Lot number of the suresound not provided by the complainant, therefore the expiration date is unknown.The suresound is not being returned therefore, a failure analysis of the complaint device can not be evaluated.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.(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: 4044736
• MDR Text Key: 17693334
• Report Number: 1222780-2014-00133
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SOUND12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2014
• 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 - SERIAL NUMBER UNK
• Patient Outcome(s): Other