MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 50-250XL

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.

Event Description

It was reported that during the procedure, the physician noticed small metal fragments in the uterus.They had to spend time to remove the fragments from the patient.The device was inspected after the procedure and there were no significant signs of damage to the scope that would account for the metal fragments.There were no adverse effects reported and the patient was discharged as planned.No additional details available at this time.

• Brand Name: MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, ma ; 2636130
• MDR Report Key: 9862965
• MDR Text Key: 184386722
• Report Number: 1222780-2020-00061
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 25420045510330
• UDI-Public: (01)25420045510330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-250XL
• Device Catalogue Number: 50-250XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1