MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	50-501XL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2024
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.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 a myosure procedure on (b)(6) 2024, metal fragments were observed during the patient surgery, two devices were used on the same patient and both exhibited the same issues.The physician stopped the procedure and aspirated all metal parts.Physician reported that most had been removed and will not have impact on the patient.Patient was a 53 years old woman , in which a myoma of 2.2 was removed.No additional information reported.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, and there were no signs of physical damage.The blade was in open position.Functional testing was conducted and the device showed an excessive torque error.A dissection test was performed and the switch did not work as intended, the wire switch was damaged inside the connector.Hence, the failure mode reported by the customer was not replicated during the investigation.However, a new failure mode was observed.This observation will be monitored and trended.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• 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; san jose 20102
• MDR Report Key: 18970060
• Report Number: 1222780-2024-00125
• Device Sequence Number: 17651183
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(17)260606(10)23F22RC
• Combination Product (Y/N): N
• Initial Reporter Country: NE
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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 Expiration Date: 06/06/2026
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 23F22RC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 01/27/2025
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 03/25/2024; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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: Unknown