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

Catalog Number SOUND12-923001-01

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 10/07/2016

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# 1222780-2016-00270.It was reported the physician attempted to perform a novasure endometrial ablation on (b)(6) 2016 and received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices.After the physician removed the second device, a hysteroscopy was performed and the physician saw a small perforation.No intervention was required.The procedure was aborted and the patient was discharged home.

• Brand Name: SURESOUND
• Type of Device: UTERINE 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 Key: 6103664
• MDR Text Key: 59975018
• Report Number: 1222780-2016-00273
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SOUND12-923001-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• 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: LOT # 16C28RC; RADIO FREQUENCY CONTROLLER - SERIAL NUMBER# UNK
• Patient Outcome(s): Other