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

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported that a physician performed an uneventful myosure procedure for uterine tissue removal on (b)(6) 2015 and the pt was discharged home.Three days later, the pt "experienced bleeding which stopped that night".The next day the pt "began to bleed heavily".The pt reported to the physicians office and the "pt had [blood] clots along with discharge so the doctor inserted a foley catheter for 48 hours".The catheter was removed after with no complications.

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 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.Reference internal complaint cc#(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, mgr ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4847729
• MDR Text Key: 5873003
• Report Number: 1222780-2015-00103
• 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: 05/11/2015

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: 05/11/2015
• Initial Date FDA Received: 06/10/2015
• 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,; UNIT- SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPE-SERIAL # UNK
• Patient Outcome(s): Required Intervention