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

Model Number 60-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: 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 and a definitive root cause for the reported event could not be determined.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 Description

It was reported that on (b)(6) a novasure procedure was performed, the doctor attempted to seat the novasure device following an initial hysteroscopy to inspect the cavity and measurement step with the sure sound.Cavity dimensions were 4.5.By 4.6.The physician was concerned with how the device was seated in the patient's uterus.The physician performed a second hysteroscopy and determined there was a potential perforation indicated by a rising deficit with no cervical leakage per the physician's comments.The case was aborted prior to a cavity assessment being performed.Additional information received the patient was fully recovered.No additional information available.

• Brand Name: OMNI HYSTEROSCOPE STANDARD SET
• Type of Device: 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 zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 17573968
• MDR Text Key: 321450686
• Report Number: 1222780-2023-00279
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045510258
• UDI-Public: 15420045510258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 60-200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other