MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL DEVICE

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 10/12/2014

Event Type  Injury  

Event Description

It was reported that prior to a myosure procedure for uterine tissue removal on (b)(6) 2014, the physician performed a dilatation and curettage (d&c) and resected a myoma.The myosure procedure was completed and the patient was discharged home."three days later the patient continued to bleed.The patient ended up going to the emergency room and an ultrasound showed blood clots which the doctor drained.Patient is now doing fine.

Manufacturer Narrative

Lot and serial number of the disposable device not provided by complainant, therefore, the expiration date is not known.Concomitant product: serial number of the myosure control unit and hysteroscope not provided by complainant.The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore, the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the lot number was not provided by the complainant.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4320374
• MDR Text Key: 5210414
• Report Number: 1222780-2014-00210
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2014

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 Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT, SERIAL # UNK; MYOSURE HYSTEROSCOPE, SERIAL # UNK
• Patient Outcome(s): Required Intervention