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

Model Number	30-401LITE
Medical Device Problem Codes	Suction Problem (2170); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received a myosure procedure on an unknown date.The customer reported that during the procedure the device wasn´t pulling fluid through the shaft and that there was a possibility of tissue not being pulled.Another device was opened the device experiencing the loss of suction was exchanged.Hologic followed up with the customer and it was reported that the procedure was completed successfully, no patient injury reported, no tissue lost and no medical intervention required.However, during an investigation on (b)(6) 2026, when opening the device it was found that inside the tubbing tissue sample tissue from the procedure was found.This sample is unusable for pathology testing thus it is considered lost.Additional visual inspection on the device revealed that the tubing had been cut, and a metal piece was fund inside one of the screws that holds the handle together which is not related to the tubing.A suction test could not be performed due to the cutting of the tube and a blockage was observed related to the pathology being stuck.The inner cannula had scratches on the inside and metal particles were observed inside the handle.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection on the device revealed that the tubing had been cut, and a metal piece was fund inside one of the screws that holds the handle together which is not related to the tubing.A suction test could not be performed due to the cutting of the tube and a blockage was observed related to the pathology being stuck.The inner cannula had scratches on the inside and metal particles were observed inside the handle.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H6: appropriate health impact term/code not available: proposed code: loss of sample.

• Brand Name: MYOSURE 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: 24775474
• Report Number: 1222780-2026-00155
• Device Sequence Number: 6065552
• Product Code: HIH
• UDI-Device Identifier: 15420045505070
• UDI-Public: (01)15420045505070(17)280419(10)25E05RU
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142029
• 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): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 25E05RU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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