MAUDE Adverse Event Report: HOLOGIC, INC SURESOUND; UTERINE SOUNDING DEVICE

Model Number NS2007KIT

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

Patient Problem Uterine Perforation (2121)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device or the radio frequency controller as the identification numbers were not provided by the complainant.Internal reference #: (b)(4).

Event Description

This is the second of two hologic reports relating to this event.Please see 1222780-2019-00222 for the second report.It was reported that prior to the endometrial ablation, a laparascopic tubal ligation was performed.The endometrial ablation procedure was performed and the physician viewed the cavity.Hologic representative noticed that it appeared the cervix was ablated and not the endometrium.The physician stated he had some confusion as to what to measure during the procedure and wanted to repeat the ablation.Hologic representative stated that this is off label use but the physician still re-inserted the device to attempt re-ablating the cavity.The physician seated the device and stated he felt no resistance but was concerned he had perforated the uterus and the procedure was aborted.A perforation was not confirmed as visualization in the cavity was difficult due to bleeding.Hologic representative states the perforation could have occurred during the sounding portion of the procedure.As far as holgic representative is aware, the patient was discharged as planned.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9109715
• MDR Text Key: 160766596
• Report Number: 1222780-2019-00221
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NS2007KIT
• Device Catalogue Number: NS20007KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• 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
• Patient Outcome(s): Other