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

Model Number	50-501XL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a myosure tissue removal the physician noted a metallic fragment in the patient's uterus."it came out and was collected in the tissue trap where it was sent to pathology to be examined." the procedure was completed.No injury reported.Additional information noted that pathology did identify a metallic fragment in the sample.
Additional Manufacturer Narrative
The reported device was received for investigation/evaluation.Examination of the blade edge showed some mild blade damage, but not fragmented as suggested.The observation will be monitored and trended.
Additional Manufacturer Narrative
As of today the reported device has not been returned for investigation.If the device is returned a follow up will be filed.

• Brand Name: MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Common Device Name: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8496002
• Report Number: 1222780-2019-00080
• Device Sequence Number: 13861485
• Product Code: HIH
• UDI-Device Identifier: 35420045505098
• UDI-Public: 35420045505098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 18M19RV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 05/20/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/08/2019; 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1