MAUDE Adverse Event Report: HOLOGIC SURESOUND

Catalog Number SOUND12

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 02/19/2014

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 1222780-2014-00039.It was reported that during a novasure endometrial ablation "the patient started to wake, and attempted to sit up with the [disposable] device still in her." the patient became restless, but after several attempts by the doctor and anesthesiologist to restrain her, the patient finally was sedated."the doctor chose to remove the device and view the cavity where she noted bubbling in the patients left cornea and peritoneal fluid accumulating.The doctor decided to abort the procedure, and believes that when the patient attempted to sit up the uterus was perforated.There was no bleeding at the site where the perforation was, and no treatment given.The patient was not hospitalized." the patient was discharged home one hour after the procedure.

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.(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: 3698625
• MDR Text Key: 4336291
• Report Number: 1222780-2014-00040
• 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: 02/19/2014

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: 02/19/2014
• Date Manufacturer Received: 02/19/2014
• 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