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 Problem Bowel Perforation (2668)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).

Event Description

It was reported that a myosure tissue removal was completed on (b)(6) 2019.The fluid deficit rose and the physician stopped the procedure at a deficit of 2400ml with the suspicion of a perforation, but did not confirm at that time.The patient was discharged home and returned to the hospital "over the weekend as she was not doing well." a laparoscopy was performed and a bowel perforation was found.An ileostomy was completed.The patient has since been discharged and is doing well.

• 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
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8624519
• MDR Text Key: 145526350
• Report Number: 1222780-2019-00124
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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 Expiration Date: 01/07/2022
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 19A07RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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: FLUENT CONSOLE: SN UNKNOWN
• Patient Outcome(s): Hospitalization; Other; Required Intervention