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

Catalog Number 30-401LITE

Device Problems Mechanics Altered (2984); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

Myosure lite tissue removal device malfunctioned."when deployed it did not disengage immediately when foot taken off foot pedal.It was unplugged and reinserted into the machine and tested outside the pt.Still did not function." no harm to pt and procedure completed with another device.Fda safety report id# (b)(4).

• Brand Name: MYOSURE LITE TISSUE REMOVAL
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; marlborough MA 01752
• MDR Report Key: 15597254
• MDR Text Key: 301865689
• Report Number: MW5112606
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 13624486
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female