MAUDE Adverse Event Report: HOLOGIC, INC MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 30-401LITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.

Event Description

It was reported that a patient, 9 weeks post cesarean section, underwent a myosure procedure to remove retained placenta.Prior to procedure, patient had pre-operative imaging done due to potential arteriovenous malformation.Post imaging, a hysterscope showed no active bleeders at the time, so the procedure went on.During the course of the procedure, patient began to bleed which eventually obscured the myosure scope vision.Physician converted to curettage since he could not use the myosure blindly.A balloon catheter was inserted into the patient and she received medications for hemostasis.Patient was transferred to interventional radiology to embolize the bleeding uterine arteries.Patient required a blood transfusion but has remained stable.Patient did not go to intensive care unit.

• Brand Name: MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 8692931
• MDR Text Key: 147793427
• Report Number: 1222780-2019-00150
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2019

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 Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other; Required Intervention