MAUDE Adverse Event Report: HOLOGIC SURESOUND; UTERINE SOUNDING DEVICE

Catalog Number SOUNDPRD-02620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 05/15/2014

Event Type  Injury  

Event Description

Note: this report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report #1222780-2014-00099.It was reported that a physician performed a novasure endometrial ablation on (b)(6) 2014.The physician received an unsuccessful cavity integrity assessment (cia) test.The physician removed the disposable device and rechecked the patient's measurements and noticed the hysteroscope traveling "far into the cavity-noted".The physician perforated and aborted the procedure.The patient was admitted into the hospital overnight for observation.The physician prescribed antibiotics for seven days and norethisterone (brand name unknown) to assist with the patient's menorrhagia.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 instrument may have been the cause.

Manufacturer Narrative

Lot number of the sure-sound not provided by the complainant, therefore the expiration date is unknown.The sure-sound is not being returned therefore, a failure analysis of the complaint device can not be completed.Lot number of the sure-sound not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review could not be conducted for the sure-sound as a lot number was not provided by complainant.Reference internal complaint cc#: (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: 3901516
• MDR Text Key: 4647719
• Report Number: 1222780-2014-00098
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SOUNDPRD-02620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention