MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 10-401FC

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

Patient Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 02/09/2019

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been 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 and sterile lot review were unable to be conducted for the disposable device as the lot number was not provided by the complainant.Internal complaint reference: (b)(4).

Event Description

It was initially reported that during the use of a myosure tissue removal device that a uterine perforation and bowel resection occurred.The patient was rushed to the hospital for emergency surgery.Additional information obtained noted that for hysteroscopic fluid distention saline was used from an iv bag with a blood pressure cuff, along with wall suction for outflow.Ultrasound guidance was employed during the procedure.The fibroid was noted to have an intramural component, located on the lateral sidewall, approximately 2.5cms.After noting adequate visualization with hysteroscopy the myosure device was inserted and the physician then experienced difficulty visualizing the cavity.To improve the visual field the physician inserted the device further into the cavity while activating the cutting mechanism of the myosure.The visual field was still not cleared, but it became apparent that a uterine perforation had occurred.Further investigation revealed a perforation of the small bowel requiring resection and primary anastomosis.The fluid deficit was 1 liter.

Manufacturer Narrative

As of today the reported device has not been returned for evaluation.If the device is returned a follow up will be filed as needed.

• Brand Name: MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8404036
• MDR Text Key: 138246147
• Report Number: 1222780-2019-00049
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention