MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE HOLOGIC; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 30-401LITE

Device Problems Material Disintegration (1177); Unintended Ejection (1234)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Patient boarded for a hysteroscopy, dilatation and curettage with myosure.Disposable myosure handpiece #30-401lite, lot #20m04r was dispensed onto the sterile field.During product use it ejected plastic shards into the uterine cavity.A second handpiece #101-401fc, lot # 21f17r was opened for use and failed in operation as the plastic pieces were caught in the oscillating tip.The cavity was irrigated with fluid but it remains unclear if all the plastic shards were removed.Fda safety report id# (b)(4).

• Brand Name: MYOSURE HOLOGIC
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 12540114
• MDR Text Key: 273798198
• Report Number: MW5104228
• Device Sequence Number: 1
• Product Code: HIH
• 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: 09/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 20M04R
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR