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

Model Number	20-401ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2024
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.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.Other.
Event or Problem Description
It was reported that on september 26, a myosure procedure was performed to remove a uterine polyp and during the procedure a green plastic was coming out of the device, at the end of the procedure the green plastic fell inside the patient's cavity and the dcotor had to removed the material.The patient was discharged home.All visualized plastic pieces were collected.No additional information available.
Additional Manufacturer Narrative
Device was returned: visual inspection was conducted, and the green piece of plastic was observed in the blade.Functional testing was not conducted due to the issue was confirmed in the visual inspection.Dissection test was performed and was confirmed that the piece of plastic is the blade positioning stop.Hence, the complaint can be confirmed.This observation will be monitored and trended.H6: investigation findings: appropriate term/code not available: suggested code: material found on device.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• Brand Name: MYOSURE MANUAL
• 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: 20364147
• Report Number: 1222780-2024-00368
• Device Sequence Number: 12482244
• Product Code: HIH
• UDI-Device Identifier: 15420045507937
• UDI-Public: (01)15420045507937(17)270506(10)24E06RC
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 20-401ML
• Device Catalogue Number: 20-401ML
• Device Lot Number: 24E06RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female