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

Model Number	40-902
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that during a myosure/omni procedure on (b)(6) 2026, the physician was using an omni scope for hysteroscopy and began a myosure procedure using a reach device.After inserting the myosure reach through the scope the physician visualized what was believe to be a piece of plastic on the distal end of the myosure device.The device had not been activated after being inserted into the scope and the material was seen before any use of the device in the patient.The physician removed the scope from the patient and the tech removed the piece from the end of the device.The piece was reported as appeared a piece of the scope seal from the end of the scope.Staff reported that there was no material observed on the end of the device prior to insertion into the patient.The material was discarded and the physician continued the procedure without observing any additional material in the uterus.The physician reported that the procedure was completed successfully.No patient injury reported and no medical intervention required.Staff examined the scope seal at the end of the procedure and determined that it did appear as a piece of the seal had been broken off.Customer was unable to provide either the scope or the myosure lot number.No other information availlable.
Additional Manufacturer Narrative
Additional information was received: customer reported that the scope seals were thrown away and will not be returning for investigation.Hologic received an image in which damage could be observed to the center of the seal.No further testing could be performed since the device was not returned.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 24501158
• Report Number: 1222780-2026-00097
• Device Sequence Number: 9870146
• Product Code: HIH
• UDI-Device Identifier: 15420045505100
• UDI-Public: 15420045505100
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 40-902
• Device Catalogue Number: 40-902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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