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

Model Number 50-501XL

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) a myosure procedure was performed and during the procedure, the doctor was resecting a calcified fibroid and had used 2 xl devices that had both become dull from cutting and was opening a 3rd device to continue removal.The doctor plugged in the 3rd device and began to continue the resection.The doctor was applying some pressure/torque to the device to keep cutting the fibroid.There was an audible change in sound, then the vibration stopped, then the machine stopped.During resection with the 3rd device, the screen on the myosure control unit went black and the device stopped.The doctor removed the device and staff power cycled the control unit to continue the procedure.The doctor reintroduced the scope after the power cycle and visualized metal shavings in the cavity.The doctor then opened a myosure reach to try and remove the metal shavings from the cavity.It was removed as many shavings as possible and the doctor chose to abort the procedure as they were approaching the deficit limit.At this time, the patient is not being kept for further observation and was not provided with any additional medication or treatment.No additional information available.

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.3 devices were involved in this case: 1222780-2024-00094 and 1222780-2024-00095.

• Brand Name: MYOSURE XL
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough 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: 18857070
• MDR Text Key: 337119601
• Report Number: 1222780-2024-00093
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(17)260906(10)23J20RL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142029
• 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,Followup
• Report Date: 05/03/2024

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: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 23J20RL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female