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 10/04/2016

Event Type  Injury  

Manufacturer Narrative

The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed.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# 1222780-2016-00259.It was reported the physician performed a novasure endometrial ablation on (b)(6) 2016.The physician received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices.The physician performed a laparoscopy and noted a perforation.On (b)(6) 2016, it was reported the patient was admitted into the hospital and discharged after two days.It is unknown if intervention was required.The patient returned to the office for follow up and is "doing well." dilatation (not a 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 (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6079181
• MDR Text Key: 59182728
• Report Number: 1222780-2016-00263
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SOUND12-923001-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• 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: RADIO FREQUENCY CONTROLLER - SERIAL NUMBER# UNK
• Patient Outcome(s): Hospitalization; Required Intervention