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

Model Number	10-401FC
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a myosure procedure on (b)(6) 2024, the physician reported that the tissue removal device was not working properly.A new device was retrieved and completed the procedure.No patient injury reported during the procedure.The device was returned for investigation and on march 5th 2025, visual inspection was conducted, and a orange piece of plastic was observed.Functional testing was conducted and the device was working correctly but was not suctioning due to the protector found inside the blade.Internal inspection was performed and scratches on the blade were observed.No other information available.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 24749862
• Report Number: 1222780-2026-00154
• Device Sequence Number: 15630251
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: (01)15420045504530(17)260531(10)23F16R
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 23F16R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown