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

Model Number NS2013KIT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

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.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 a novasure endometrial ablation the suresound device was used and it was noted that pieces from "the plastic part that deploys and expands at os" had broken off in the uterine cavity.The pieces were retrieved and the cavity was clear on hysteroscopy.The ablation was completed successfully with no injury reported.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8425339
• MDR Text Key: 138970448
• Report Number: 1222780-2019-00054
• 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: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: NS2013KIT
• Device Catalogue Number: NS2013KIT
• Device Lot Number: 18M03RC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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