MAUDE Adverse Event Report: HOLOGIC SURESOUND; UTERINE SOUNDING DEVICE

Catalog Number SOUND12

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

Patient Problem Internal Organ Perforation (1987)

Event Date 05/23/2014

Event Type  Injury  

Event Description

This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, mfr's report #1222780-2014-00105.It was reported that prior to a novasure endometrial ablation on (b)(6) 2014, the physician performed a hysteroscopy and noted a uterine perforation (location unk).The physician decided to continue on and to attempt the novasure procedure.Reportedly, the procedure was completed successfully and there was no medical intervention or treatment required.The pt was discharged home and is "doing ok".A hysteroscopy and dilation, (not hologic devices) were performed prior to the ablation.It is not know when this 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 know.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 mfr 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.Ref 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: 3925631
• MDR Text Key: 4581387
• Report Number: 1222780-2014-00104
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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: 05/30/2014
• 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 NUMBER UNK
• Patient Outcome(s): Other