MAUDE Adverse Event Report: Hologic, Inc. OMNI; Hysteroscope accessories

Model Number	OMNI-S-001
Medical Device Problem Codes	Entrapment of Device (1212); Material Fragmentation (1261); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As soon as it was put threw the sheath it came out the other end one of the blades shredded in a few pieces.We then removed the scissors, yet unfortunately there was metal and metal shavings left inside the patient from the defective scissors.Dr.Was able to remove the shavings by opening up a lite shaver.Then sending whole specimen to the lab for diagnostic assessment.

• Brand Name: OMNI
• Common Device Name: Hysteroscope accessories
• Manufacturer (Section D): Hologic, Inc.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 50713484
• Report Number: 50713484
• Device Sequence Number: 10005405
• Product Code: NWW
• UDI-Device Identifier: 15420045515529
• UDI-Public: (01)15420045515529
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026
• Report Date (Section F): 06/24/2026

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 Model Number: OMNI-S-001
• Device Catalogue Number: OMNI-S-001
• Device Lot Number: 25F13RL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/24/2026