MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ADVANCED ENDOMETRIAL ABLATION; HYSTEROSCOPE AND ACCESSORIES

Model Number NS2013US

Device Problem Defective Component (2292)

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

Event Date 12/07/2018

Event Type  malfunction  

Event Description

Myosure device did not work.Rep was present and could not make it work either.Novasure device was placed and deployed.The co2 test failed.A second tenaculum was used and it failed a second time.There was no evidence of leakage around the cervix.A repeat hysteroscopy was performed.Reason for use, hysteroscopy with polyp and submucous myoma resection.

• Brand Name: MYOSURE ADVANCED ENDOMETRIAL ABLATION
• Type of Device: HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): HOLOGIC, INC
• MDR Report Key: 8301198
• MDR Text Key: 135518768
• Report Number: MW5083648
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NS2013US
• Device Lot Number: 17F05RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2019
• 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: 72 YR
• Patient Weight: 56