MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE SURESOUND ENDOMETRIAL ABLATION SYSTEM ; SOUND, UTERINE

Catalog Number NS2007US

Device Problem Failure to Fire (2610)

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

Event Date 06/18/2019

Event Type  malfunction  

Event Description

During hysterectomy, device did not fire when pedal was activated.Attempted three more times, unsuccessfully.New device was then opened and used.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: NOVASURE SURESOUND ENDOMETRIAL ABLATION SYSTEM
• Type of Device: SOUND, UTERINE
• Manufacturer (Section D): HOLOGIC, INC. ; marlborough MA 01752
• MDR Report Key: 8730838
• MDR Text Key: 149261673
• Report Number: MW5087574
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NS2007US
• Device Lot Number: (01)15420045501133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 63