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

Catalog Number SOUND12

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Perforation (2001)

Event Date 03/14/2016

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.Mfg date: 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).

Event Description

Note: this report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2016-00094.It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016 and the physician received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices.The physician "viewed a perforation in the center of the uterus".A laparoscopy was performed and the physician cauterized the perforation.The procedure was aborted.It is unknown if the patient was discharged home.We have been unable to obtain additional information surrounding this event.Dilatation performed (not a hologic device) 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: 5574632
• MDR Text Key: 42606149
• Report Number: 1222780-2016-00095
• 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
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• 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: 03/14/2016
• 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: N
• Patient Sequence Number: 1
• Treatment: RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK
• Patient Outcome(s): Required Intervention