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

Catalog Number	50-501XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being 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.(b)(4).
Event or Problem Description
It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2018, and the patient was "actively bleeding" at the fibroid removal site.The patient had low hemoglobin (hb) and the physician aborted the procedure.The physician inserted a catheter to try and tamponade the bleeding.The patient continued to bleed and the physician decided to proceed with a laparoscopic hysterectomy.The patient received a blood transfusion intraoperatively.The findings were the patient had a bulky uterus which was thought to have underlying pathology causing the intermittent cyclic bleeding.The patient recovered well and was discharged the next morning.

• Brand Name: MYOSURE XL TISSUE REMOVAL SYSTEM
• Common Device Name: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7575124
• Report Number: 1222780-2018-00117
• Device Sequence Number: 2044367
• Product Code: HIH
• UDI-Device Identifier: 35420045505098
• UDI-Public: 35420045505098
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K122498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: Physician
• Device Expiration Date: 04/19/2020
• Device Catalogue Number: 50-501XL
• Device Lot Number: 17D19RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MYOSURE CONTROL UNIT: SN# UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention