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

Model Number	10-401FC
Medical Device Problem Codes	Decrease in Suction (1146); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a myosure procedure on (b)(6) 2025 the customer reported that the myosure device stopped cutting halfway through the procedure as well as experiencing issues with excessive torque.The procedure was reported to have been completed with a third device without further issue and no patient injury reported nor medical investigation required.The device was returned for investigation and the investigation was closed on january 16th 2026, which revealed that initially there were no signs of physical damage and that the window was in the open position.Inside the blade and in the window the positioning plug was observed.Functional testing was performed and the device was cutting tissue but not suction during the testing phase.No additional information available.
Additional Manufacturer Narrative
Visual inspection was conducted, and there were no signs of physical damage.The window was in open position and the blade positioning plug was be observed.Functional testing was conducted, and the device was cutting the tissue but not suctioning during the test.Hence, the complaint can be confirmed.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• 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: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 24203541
• Report Number: 1222780-2026-00043
• Device Sequence Number: 5495389
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: (01)15420045504530(17)280316(10)25D01RL
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/28/2026

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 Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 25D01RL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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