MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL FOR FLUENT DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	50-601XL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
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.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 post a myosure procedure on (b)(6) 2026, metal shavings were noted in the uterine cavity.During the procedure, the white cable cord was bouncing around, and the excessive torque warning was on the display throughout the procedure.The physician was reported to use force to cut the calcified fibroid.The physician removed the shavings with the outflow channel but was unable to retrieve it entirely.The patient is stable and did not require any additional medication or imaging and was not admitted after the procedure.Customer reported that the concomitant hysteroscope and outflow channel were examined for any damage and that none was observed no other information is available.

• Brand Name: MYOSURE XL FOR FLUENT 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: 24404881
• Report Number: 1222780-2026-00072
• Device Sequence Number: 9859199
• Product Code: HIH
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181974
• 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): 06/22/2026

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: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 24C11RC
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 60-200
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown