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 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been 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.Internal complaint reference: (b)(4).

Event Description

It was reported that during a novasure endometrial ablation the physician utilized the suresound device and noticed when removing the device that pieces were missing."he scoped the patient and saw the broken pieces and resected them from the patient." the novasure was completed.No injury reported.

Manufacturer Narrative

The returned device was received and it was confirmed that the prongs were broken.The exact root cause is unknown at this time.This issue has been escalated for review and capa-02785 has been initiated.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8527801
• MDR Text Key: 145117642
• Report Number: 1222780-2019-00090
• Device Sequence Number: 1
• Product Code: HHM
• UDI-Device Identifier: 35420045501120
• UDI-Public: 35420045501120
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: NS2013KIT
• Device Catalogue Number: NS2013KIT
• Device Lot Number: 19A10R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1