MAUDE Adverse Event Report: HOLOGIC SURESOUND

Catalog Number SOUND12

Device Problem Device Handling Problem (3265)

Patient Problems Pain (1994); Uterine Perforation (2121)

Event Date 02/13/2014

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 number 1222780-2014-00046.It was reported that during a novasure endometrial ablation on (b)(6) 2014, a physician received two unsuccessful cavity integrity assessment (cia) tests.The physician removed the disposable device and performed a hysteroscopy.There was no perforation found.The procedure was aborted and the patient was discharged home."approximately 24 hours post attempted ablation, the patient reported chest pain.Upon observation on or around (b)(6) 2014, the patient is found with air under diaphragm." possible perforation suspected.It was reported on (b)(6) 2014, the patient was "just observed for 24 hours" and "the patient is doing fine." a hysteroscopy and dilatation, (not hologic devices) were performed prior to the attempted ablation.It is not known when the suspected 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 not known.The suresound is not being returned therefore, a failure analysis of the complaint device cannot 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.(b)(4).

• Brand Name: SURESOUND
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, manager ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3698627
• MDR Text Key: 4336292
• Report Number: 1222780-2014-00053
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• 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
• Distributor Facility Aware Date: 02/13/2014
• Date Manufacturer Received: 02/18/2014
• 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 #UNK
• Patient Outcome(s): Other