MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL FOR FLUENT DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-601XL

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Myosure tissue removal device that was defective today during a case.Stopped working and representative was called.

• Brand Name: MYOSURE XL FOR FLUENT DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 13175433
• MDR Text Key: 283308465
• Report Number: 13175433
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 21H26RB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1