MAUDE Adverse Event Report: HOLOGIC, INC OMNI HYSTEROSCOPY STANDARD SET; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	60-250-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the reusable device at the time of this report a follow up report will follow with the information.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 during a myosure procedure on (b)(6) 2025, resulted in a perforation.The patient was a 61-year-old female.The patient presented with a thickened cystic endometrium and was scheduled for a hysteroscopy with dilation and curettage and possible polypectomy.A vaginoscopic approach with hydro dilation was performed using a standard diagnostic hysteroscope, fluid bag, arthroscope giving set.Fluid bag in a pressure bag 1l saline was used with arthroscope giving set.A polyp was identified and the omniscope with myosure was introduced under direct visualization.Initially, the polyp was briefly visualized but then the views become unclear.The physician attempted activation of the myosure device to improve visualization, but the view did not improve.Poor visualization followed by appearance of yellow tissue raised concern for uterine perforation.The procedure was converted to laparoscopy for further assessment.Intraoperatively, the perforation site was identified and over-sewn with 2/0 monocryl.The polyp was resected with excellent visualization.A repeat laparoscopy confirmed hemostasis.The uterine perforation was 5.5 mm.The patient was monitored overnight, remained stable and was discharged the next day.No device anomalies were identified.No sounding was performed.No ablation was conducted during the procedure.No other information is available.
Additional Manufacturer Narrative
Additional information received: unique device identifier (udi) is (b)(4).A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.Device will not be returning.
Additional Manufacturer Narrative
The correct date of this report is november 13, 2025.

• Brand Name: OMNI HYSTEROSCOPY STANDARD SET
• 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: 23542364
• Report Number: 1222780-2025-00570
• Device Sequence Number: 9683171
• Product Code: HIH
• UDI-Device Identifier: 15420045510258
• UDI-Public: (01)15420045510258
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K182006
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 60-250-1
• Device Catalogue Number: 60-250-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: Not provided; 11/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/13/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown