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

Catalog Number 10-401XL

Device Problem Insufficient Information (3190)

Patient Problem Hypovolemia (2243)

Event Date 03/24/2015

Event Type  Injury  

Event Description

It was reported that a physician performed a myosure procedure for uterine tissue removal on (b)(6) 2015 and the fluid deficit rose to "4000ml'.The pt was admitted into the hospital and received lasix.The pt was discharged the following day and the doctor reported the "pt is doing well".

Manufacturer Narrative

Lot number of the disposable device not provided by the complaint, 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 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 complaint.(b)(4).

• Brand Name: MYOSURE XL 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: 4665081
• MDR Text Key: 20749017
• Report Number: 1222780-2015-00050
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122498
• 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: 03/02/2015

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: 10-401XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 04/02/2015
• 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; MYOSURE HYSTEROSCOPE - SERIAL # UNK; CONTROL UNIT - SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Required Intervention