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

Model Number	OMNI-S-001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) and during the procedure was used a set of omni scissors with a myosure scope prior to a myosure procedure.When the doctor removed the scissors from the scope to introduce the myosure device, the doctor noticed what looked like metal shavings in the cavity.The doctor inserted the myosure device into the cavity and removed the shavings from the cavity prior to resecting any tissue.The doctor used a second set of scissors to complete the procedure after the myosure portion was completed.The scope and scissors were inspected post-procedure and there did not appear to be any damage from what they could tell.The doctor was satisfied with the results of the myosure device removing any debris from the cavity; no debris was left in the cavity.Patient was fine and was not kept for any further observation.No additional information available.
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.

• 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 ; CR 20102
• MDR Report Key: 20573629
• Report Number: 1222780-2024-00406
• Device Sequence Number: 8170783
• Product Code: NWW
• UDI-Device Identifier: 15420045515529
• UDI-Public: (01)15420045515529(17)260516(10)24D26RL
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 05/16/2026
• Device Model Number: OMNI-S-001
• Device Catalogue Number: OMNI-S-001
• Device Lot Number: 24D26RL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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
• Patient Sex: Unknown