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

Catalog Number 10-401

Device Problem Pressure Problem (3012)

Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331)

Event Date 12/19/2014

Event Type  Injury  

Event Description

It was reported that a physician performed a myosure procedure for uterine tissue removal on (b)(6) 2014.The physician started to cut and the patient exhibited some bleeding.The physician removed the device and tried to view the cavity but could not get enough pressure and distention.The physician aborted the procedure performed a dilatation and curettage (d&c).The fluid deficit was 1250ml.The physician administered "2 grams of ancef" as the patient was still bleeding.She looked at the patient's urine which was clear and yellow.She administered pitressin and placed a foley intrauterine to control active bleeding.On (b)(6) 2015, it was reported by the nurse that the patient did not have a hysterectomy and there were no perforations.The patient was brought back for a exploratory laparotomy.

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 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 mfr 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.(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: 4456928
• MDR Text Key: 5327033
• Report Number: 1222780-2015-00013
• 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: 12/19/2014

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: 12/19/2014
• Initial Date FDA Received: 01/16/2015
• 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 HYSTEROSCOPE - SN: UNK; CONTROL UNIT - SN: UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM,
• Patient Outcome(s): Required Intervention