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

Model Number 10-401 FC

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/30/2018

Event Type  Injury  

Event Description

The patient came to the ed with heavy uterine bleeding.Physician performed hysteroscopy and myomectomy with myosure.The physician went to perform the myomectomy.The staff connected the myosure reach device and the device would not move and remained in the case.The hologic representative was contacted.A new device was obtained.The procedure was delayed by 10-15 minutes.The new device was attached and worked.The defective device was sent back to hologic.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC INC.
• MDR Report Key: 8213834
• MDR Text Key: 132362574
• Report Number: MW5082817
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 10-401 FC
• Device Lot Number: 18H16RF
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 70