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

Model Number NS2013KIT

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

Patient Problem Uterine Perforation (2121)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).

Event Description

It was reported that during an attempted novasure endometrial ablation the physician "had a difficult time dilating the patient and couldn't find the tract." the procedure was aborted due to a suspected perforation.The novasure device was not inserted into the uterus, but the suresound device was utilized.The perforation was not confirmed.No additional information was received.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 8052898
• MDR Text Key: 126638470
• Report Number: 1222780-2018-00234
• Device Sequence Number: 1
• Product Code: HHM
• UDI-Device Identifier: 35420045501120
• UDI-Public: 35420045501120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010013
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: NS2013KIT
• Device Catalogue Number: NS2013KIT
• Device Lot Number: 17K31RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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