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

Model Number	50-501XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.2 devices were involved in this event: 1222780-2023-00372 and 1222780-2023-00373.
Event or Problem Description
It was reported that on (b)(6) a myosure procedure was performed and during the procedure, the doctor paused the use of myosure as she stated that she felt like she was not making much progress on removing the fibroid.The doctor then attempted to use polyp forceps to remove the remainder of the fibroid.When the doctor re-entered the cavity with the scope, it was observed what seemed to be a false passage further past the natural cavity.The procedure was ended.No additional information available.

• Brand Name: MYOSURE XL
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 17900982
• Report Number: 1222780-2023-00372
• Device Sequence Number: 6998739
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(17)250215(10)22C03RD
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142029
• 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,Followup
• Report Date (Section B): 10/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2025
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 22C03RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female