MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bleeding (1738)

Event Date 03/16/2014

Event Type  Injury  

Event Description

It was reported that during a myosure for uterine tissue removal on (b)(6) 2014, the physician performed a hysteroscopy and did not visualize fibroids or polyps in the uterine wall.The physician noted the patient's endometrium was thick and utilized the myosure device to remove the patient's thick endometrium.The procedure was completed and the patient was discharged home.On (b)(6) 2014, the patient presented to the emergency room with heavy vaginal bleeding soaking pads.She was admitted for observation and the bleeding lessened significantly with only lysteda (tranexamic acid) and ibuprofen being administered.Her [hemoglobin] hgb was 8.4, she was hemodynamically stable and did not receive any blood products.The patient was being discharged with no further intervention.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore, the expiration date is not known.Serial number of the myosure control unit and hysteroscope not provided by the 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 not able to be conducted for the myosure system as the lot number was not provided by the complainant.Reference internal complaint (b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, manager ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3760952
• MDR Text Key: 4464521
• Report Number: 1222780-2014-00057
• 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: 03/17/2014

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
• Distributor Facility Aware Date: 03/16/2014
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/10/2014
• 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 HYSTEROSCOPE, SERIAL NUMBER UNK; SALINE DISTENTION MEDIA; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT - SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Required Intervention