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

Model Number 10-550

Device Problem Failure to Cut (2587)

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

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Doctor was trying to perform a myomectomy.Myosure reach device given to the doctor.The device would not cut through uterine fibroid.All connections were checked on myosure generator.Hologic customer support called and guided the nurse through generator and device check.Device again tested and still did not work.Customer service representative suggested opening another reach device.This device also did not work.Customer service rep stated she would contact our product rep in regards to this matter.

• Brand Name: MYOSURE TISSUE REMOVAL SYSTEMCONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9082200
• MDR Text Key: 159013181
• Report Number: 9082200
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Device Lot Number: 18J06R, 18G26RP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1