MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Concomitant product(s): serial number of the myosure control unit, hysteroscope and aquilex fluid management system not provided by the complainant.The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Mfg date: 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 and the novasure system as the identification numbers were not provided by the complainant.(b)(4).

Event Description

Note: this report pertains to the second of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2016-00195.It was reported a physician performed a myosure procedure for uterine tissue removal and a novasure endometrial ablation on (b)(6) 2016.The physician had difficulty seating the electrode array due to a myoma.The physician removed the novasure device and decided to use the myosure disposable device to cut the myoma.The patient started to bleed heavily.The physician attempted to perform the novasure and received a cavity integrity assessment (cia) test.The procedure was aborted and the physician performed a hysterectomy.The patient was not admitted into the hospital.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5846253
• MDR Text Key: 51138757
• Report Number: 1222780-2016-00196
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 10-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• 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 CONTROL UNIT-SERIAL # UNK
• Patient Outcome(s): Required Intervention