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

Model Number	OMNI-S-001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Uterine Perforation (2121)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot and serial 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.
Event or Problem Description
It was reported on september 24 during a uterine surgery a omni hysteroscopic scissor was used to take down a septum.However, the doctor couldn¿t get all the way through the septum.Instead, there was a uterine perforation which led to intraabdominal hemorrhage and the patient getting transferred to cedars for a laparoscopy surgery.Additionally, customer reported that uterine perforation was a very unusual complication in which the doctor hit a artery in an unusual location at the uterine fundus and it caused intra-abdominal bleeding.Device worked as expected, no unexpected action from the device occurred and no malfunction was reported.Physician reported that the event was not related to the scissors but was an user error related to patient conditions.No additional 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 ; CR 20102
• MDR Report Key: 20509004
• Report Number: 1222780-2024-00387
• Device Sequence Number: 9087997
• Product Code: NWW
• UDI-Device Identifier: 15420045515529
• UDI-Public: 15420045515529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: OMNI-S-001
• Device Catalogue Number: OMNI-S-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown