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

Model Number	30-401LITE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the myosure procedure was performed on (b)(6) 2026, and the patient presented to the clinic on (b)(6) 2026, complaining about abdominal pain.Approximately 50 ml of blood was observed in the uterine cavity, so the patient was transported to the tertiary care facility by ambulance.The total blood loss, patient's current condition, and if the blood transfusion is administered is unknown.Due to the poor visibility during the procedure caused by bleeding, hemostatic agents were prescribed for 4 days postoperatively.There was no bleeding immediately after surgery or during the follow up visit the following day.The pathology results indicated an adenomatous polyp with a hard lesion resembling adenomyosis.Color doppler imaging confirmed blood flow near the base of the polyp.No other medical devices were used in conjunction with this procedure.The patient remains hospitalized and the patient's condition is being monitored.Additional information was reported that on (b)(6) the patient was urgently transported to a tertiary care facility, but since no treatment was required at the time of arrival, they were not admitted and were discharged the same day.Therefore, no blood transfusion was administered.On (b)(6), the patient had a follow-up visit at the hospital where the procedure was performed, and it was confirmed that there were no issues.No other information available.
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.

• 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: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 25085026
• Report Number: 1222780-2026-00198
• Device Sequence Number: 18760349
• Product Code: HIH
• UDI-Device Identifier: 15420045505070
• UDI-Public: 15420045505070
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/05/2026
• 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