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	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned: visual inspection was conducted and the tubing was cut from the device and no suction test could be performed.However, during functional testing, the device reciprocated as intended.During internal inspection, it was noted that the inner cannula was stuck and it was broken to find the blade positioning stop inside it.Therefore, 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.
Event or Problem Description
It was reported during a myosure procedure on (b)(6), that the suction failed and the suction tubing had to be cut.There was no harm to the patient reported.Upon investigation on (b)(6), it was found that the inner cannula was stuck and it was broken to find the blade positioning stop was inside it.

• 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: 24598898
• Report Number: 1222780-2026-00115
• Device Sequence Number: 15545093
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: (01)15420045504530(17)270115(10)24A31RH
• 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): 03/13/2026

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 Lot Number: 24A31RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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