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

Model Number	50-601XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2025
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 during a myosure procedure on (b)(6) 2025, the physician reported that while doing a resection of a fibroid located in the lower segment of the uterine cavity on the posterior wall, the procedure was going well and at 90% of resection, the physician started to observe small speckles/metallic dust in the endometrium.Surgeon decided to abandon the remaining procedure and attempted to flush the metallic pieces with saline solution, this was not successful.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, and the suction tube was cut off before arriving at hologic for evaluation purposes.Functional testing was conducted, and the disposable failed the mechanical test since the blade did not move, and the console displayed an ¿excessive torque error¿.Dissection test was conducted, evidence of excessive friction between the blade and the outer tube was found in the proximal part of the shaft.Additionally, metal shavings were found within the handle, probably caused by the friction between the blade and outer tube.Finally, it was also noticed that the tip of the outer tube was bent, causing issues with the blade to close the cutting window.Hence, the complaint can be confirmed.This observation will be monitored and trended.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21721398
• Report Number: 1222780-2025-00140
• Device Sequence Number: 3993661
• Product Code: HIH
• UDI-Device Identifier: 15420045507654
• UDI-Public: (01)15420045507654(17)270624(10)24G09RF
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 24G09RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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