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

Model Number	60-200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
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 hysteroscope procedure on (b)(6) 2026, the staff reported that they were using an omni hysteroscope and a storz light cord and video system.The staff placed the hysteroscope with the attached light cord on the patient´s abdomen while sounding.Smoke was observed coming from the patient´s abdomen and the hysteroscope was removed and it was noticed that the light cord had disconnected and that it had burned through the drape and burned the patient´s abdomen skin superficially.The patient was treated with ointment and gauze and the procedure was completed successfully and the patient discharged the same day.Hologic reached out for additional details and it was reported that the burn was a 1st degree burn but was not an official diagnosis.No other information available.

• Brand Name: OMNI HYSTEROSCOPE
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 24349597
• Report Number: 1222780-2026-00064
• Device Sequence Number: 13291503
• Product Code: HIH
• UDI-Device Identifier: 15420045510258
• UDI-Public: (01)15420045510258
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/16/2026

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: 60-200
• Device Catalogue Number: 60-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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: Other
• Patient Sex: Unknown