MAUDE Adverse Event Report: HOLOGIC SURESOUND; UTERINE SOUNDING DEVICE

Catalog Number SOUND12

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Uterine Perforation (2121); Therapeutic Response, Decreased (2271)

Event Date 04/28/2014

Event Type  Injury  

Event Description

Note: this report pertains to the second of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report # 1222780-2014-00081.It was reported that a physician performed a novasure endometrial ablation on (b)(6) 2014 and received an unsuccessful cavity integrity assessment (cia) test.The physician performed a hysteroscopy and noted a uterine perforation.The patient was transferred to a hospital and a physician "put a stitch in the 5mm perforation".The patient was admitted into the hospital as she opted to have a hysterectomy.The hysterectomy was completed and the patient was discharged on (b)(6) 2014.A hysteroscopy and dilation (not hologic devices) were performed prior to the attempted ablation.It is not known when this perforation occurred or what instruments may have been the cause.

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).

• 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: 3853487
• MDR Text Key: 4620614
• Report Number: 1222780-2014-00080
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• 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: 04/28/2014
• 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: SN UNK; NOVASURE DISPOSABLE DEVICE: 13F06RA
• Patient Outcome(s): Hospitalization; Required Intervention