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 Codes	Bacterial Infection (1735); Bowel Burn (1756); Bowel Perforation (2668)
Date of Event	07/10/2025
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 a patient received a combination of procedures on (b)(6) 2025 which involved a myosure reach procedure using an omni hysteroscope and, an acessa procedure.Procedures were reported as having been completed successfully.The physician later reported that the acessa procedure was unremarkable and that the procedure included treatment of three fibroids ranging from 1 to 3 cm.The patient came back on (b)(6) with severe pelvic pain, elevated white blood cell count.A ct scan did not show any perforation.Patient was kept overnight for observation and developed air in the abdominal cavity.A surgery was performed and a 5 mm perforation was observed on the small bowel with subsequent resection.Patient was reported as obese and needed retraction to keep the bowel out of the way during the procedure.Treating physician´s assumption noted that the handpiece might have touched the bowel after the use while it was still hot and this caused a thermal injury that resulted in a perforation 12 days after the surgery.No other information 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 22701432
• Report Number: 1222780-2025-00412
• Device Sequence Number: 8945117
• Product Code: HIH
• UDI-Device Identifier: 15420045507654
• UDI-Public: (01)15420045507654(17)251227(10)23A12RK
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/04/2025

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 Expiration Date: 12/27/2025
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 23A12RK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown