MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fistula (1862); Malaise (2359); No Code Available (3191)

Event Date 02/20/2014

Event Type  Injury  

Event Description

It was reported that a physician performed a mysosure procedure for uterine tissue removal on (b)(6) 2014.The physician "was able to remove approximately 50% of the pathology before the fluid deficit began to climb rapidly.She decided to stop the procedure when the fluid deficit reached 2000 ml".A couple days following the procedure the patient started "feeling sick" and presented to the emergency room (er).An "ultrasound determined that there was an abscess behind the uterus".The physician administered antibiotics and the patient was discharged home.Weeks later, the patient started to "feel worse than before" and returned to the er.The physician performed a hysterectomy and the pathology was on the"mid-wall/anterior wall of the uterus".The physician theorized that there could have been a particle of the fibroid that "fistualized" through the uterine wall.The discharged date is unknown, but the physician reported "the patient is doing well and is in good spirits".

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Concomitant product: serial number of the mysosure 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.Myosure disposable.According to the instructions for use (ifu) warnings: to avoid perforation, keep the device tip under direct visualization and exercise care at all times when maneuvering it or cutting it close to the uterine wall.Never use the device tip as a probe or dissecting tool.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4617641
• MDR Text Key: 5590843
• Report Number: 1222780-2015-00038
• 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: 02/09/2015

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: 02/19/2015
• Initial Date FDA Received: 03/12/2015
• 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): Hospitalization; Required Intervention