MAUDE Adverse Event Report: HOLOGIC MYOSURE LITE; MYOSURE LITE TISSUE REMOVAL DEVICE

Model Number 30-403LITE

Device Problems Kinked (1339); Vibration (1674); Noise, Audible (3273)

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

Myosure polyp removal device being used in hysteroscopy procedure for removal of intrauterine polyp was vibrating and noisy.Also suction to the fluid management device through the myosure device was inadequate.This is a one time use device.Cable visualized to be kinking/binding in sheath.

• Brand Name: MYOSURE LITE
• Type of Device: MYOSURE LITE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA 01752
• MDR Report Key: 6225015
• MDR Text Key: 64044974
• Report Number: MW5067048
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/03/2017

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 Expiration Date: 04/30/2019
• Device Model Number: 30-403LITE
• Device Lot Number: 16E04R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 65