MAUDE Adverse Event Report: HOLOGIC, INC OMNI; HYSTEROSCOPE ACCESSORIES

Model Number	OMNI-S-001
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	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted and there were no signs of physical damage.Functional testing was conducted and the device passed the testing, the failure reported was not reproduced.Hence, the complaint cannot be confirmed.This observation will be monitored and trended.
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 an omni procedure on (b)(6) 2025, the physician observed that there were metal shavings observed in the patient during the procedure.Physician used a myosure reach to obtain all shavings.There was no injury reported and the procedure was completed using the same device.On a follow up it was reported that the physician had used a myosure reach prior to using the scissors, the procedure performed was the removal of adhesions.No other information available.

• Brand Name: OMNI
• Common Device Name: HYSTEROSCOPE 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: 22323009
• Report Number: 1222780-2025-00336
• Device Sequence Number: 18357143
• Product Code: NWW
• UDI-Device Identifier: 15420045515529
• UDI-Public: (01)15420045515529(17)260724(10)24G04R
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2026
• Device Model Number: OMNI-S-001
• Device Catalogue Number: OMNI-S-001
• Device Lot Number: 24G04R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown