MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE ADVANCED SURESOUND; SOUND, UTERINE

Catalog Number NS2013KITUS

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  malfunction  

Event Description

Novasure would not pass the cavity assessment, it kept failing.A second device was opened and functioned as expected.Manufacturer response for impedence controlled endometrial ablation disposable, novasure advanced suresound (per site reporter) : manufacturer provided rga# and product return packaging.

• Brand Name: NOVASURE ADVANCED SURESOUND
• Type of Device: SOUND, UTERINE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7586344
• MDR Text Key: 110648710
• Report Number: 7586344
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/09/2020
• Device Catalogue Number: NS2013KITUS
• Device Lot Number: 18A09RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 89