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 Problems Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 01/07/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(6) 2014, the physician "removed three quarters of a fibroid then had to stop because it was too calcified to remove the rest." the physician performed a fluid deficit count and noted the fluid deficit to be "600ml." the patient exhibited "pulmonary edema" and was admitted.It is unknown if intervention was required.The patient was discharged two days later.We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore, the expiration date is not known.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, 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.If additional relevant information is received, a supplemental medwatch will be filed.(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: 3670369
• MDR Text Key: 4346643
• Report Number: 1222780-2014-00032
• 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: 01/30/2014

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2014
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/27/2014
• 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: CONTROL UNIT: SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; MYOSURE HYSTEROSCOPE: SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Other