MAUDE Adverse Event Report: HOLOGIC, INC SURESOUND; SOUNDING INSTRUMENT

Catalog Number SOUND12

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/09/2015

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 reference internal complaint (b)(4).The device is not being returned.

Event Description

This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# (b)(4).It was reported that during a novasure endometrial ablation on (b)(6) 2015, the physician received several unsuccessful cavity integrity assessment (cia) tests.The physician then removed the electrode array and "may have found a perforation".No intervention was required.The procedure was aborted and the patient was discharged home.Dilatation (not 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: SOUNDING INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4992220
• MDR Text Key: 22571497
• Report Number: 1222780-2015-00139
• 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
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SOUND12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK
• Patient Outcome(s): Other