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

Model Number	10-401FC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Uterine Perforation (2121)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
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 a patient underwent a myosure and sonata procedure on (b)(6) 2026.The procedure was initiated using a myosure device for a 8cm fibroid.Due to the fibroid being calcified it was difficult to resect.The physician then used the sonata device to soften the fibroid.The physician then returned to using the myosure device to start resecting the remainder of the fibroid, when it was noted that the physician resected the posterior wall of the uterus.The physician then chose to perform laparoscopy and confirmed the uterine perforation.It was confirmed that there is no injury to the rectum.The physician then sutured the uterine perforation.The patient was admitted overnight for observation.Later that evening, the patient presented to the emergency department with pain.A computed tomography (ct) scan was performed and was unremarkable.Two laboratory studies showed the patient was nontoxic.Pain subsided and the patient was discharged.The patient will be going back to the hospital for another laparoscopic procedure for follow up the week of (b)(6) 2026.Additional information was received that the patient presented with pain and low grade fever the following day and the pathology report confirmed that there was a full thickness bowel tissue present in the sample.Patient was admitted to the operating room to find the defect and no additional information was received.No other information available.

• Brand Name: MYOSURE REACH 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: 25763605
• Report Number: 1222780-2026-00434
• Device Sequence Number: 13208464
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: 15420045504530
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152723
• 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): 07/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 07/10/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown