MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE DEVICE (HANDPIECE); DEVICE, THERMAL ABLATION, ENDOMETRIAL

Catalog Number NS2013US

Device Problem Crack (1135)

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

Event Date 08/22/2019

Event Type  malfunction  

Event Description

Novasure device opened to field.Noted a crack in distal dial area of device.Exchanged out for a new device and surgery progressed as usual.Cracked novasure placed in soiled supply room cupboard.

• Brand Name: NOVASURE DEVICE (HANDPIECE)
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 8960461
• MDR Text Key: 156483399
• Report Number: 8960461
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NS2013US
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA