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 11/20/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6), a myosure procedure was performed and, during the case, the device made a crunching sound and it was noticed a piece of metal in the patient's cavity.The piece was removed with graspers and has been saved with the device.The doctor may have applied slight torque on the device a couple of times, but not much.The patient had a prior acessa and myosure procedure in (b)(6) 2023.Before that, she went to the er at another facility and had an embedded iud dealt with.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.

• Brand Name: MYOSURE XL
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18278613
• MDR Text Key: 329867305
• Report Number: 1222780-2023-00456
• Device Sequence Number: 1
• Product Code: HIH
• 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: 01/11/2024

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: 23G13RF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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