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

Model Number 10-401FC

Device Problems Crack (1135); Noise, Audible (3273)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

The myosure was making an odd noise when in use.The tech had the md pass it off the field to take a look at the device.The tech noticed it had a crack in between the handle and where the cord meet.A new myosure was opened to complete the procedure.Fda safety report id # (b)(4).

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC. ; marlborough MA 01752
• MDR Report Key: 9008692
• MDR Text Key: 158639333
• Report Number: MW5089745
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401
• Device Lot Number: 19E31RD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR