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

Model Number 2013

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Event Description

Product did not go through the full array sequence.The procedure was unable to be completed with this device.A new novasure was opened to complete the procedure.The failed product had patient contact but no patient harm.Manufacturer response for novasure, (brand not provided) (per site reporter).The product was returned to manufacturer for evaluation and a replacement product was received.

• Brand Name: NOVASURE
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 8543637
• MDR Text Key: 142887796
• Report Number: 8543637
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2013
• Device Catalogue Number: NS2013US
• Device Lot Number: 18G10R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA