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

Model Number 10-401

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

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.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.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

This is the first of two hologic reports related to this event.Please also refer to 1222780-2020-00022 for the second report.It was reported to hologic by the performing physician that in (b)(6) or (b)(6) of 2019, he had completed an uncomplicated fibroid removal procedure followed by an endometrial ablation.Both procedures were completed without incident.The physician stated "the patient went home with some discomfort however later on in the evening the patient was not feeling well." he suggested the patient go to the emergency department.The patient arrived that night at 1:00am and had blood work done with culture.The culture results were positive for strep and sepsis.The patient was monitored and prescribed medication.The patient had a laparoscopic procedure three days later to rule out any puss or infection in the abdomen."there were no findings of infection in the abdomen and all looked benign." a hysteroscopy was also performed and there was no signs of any puss or fluid build up in the uterine cavity.The physician stated the patient is doing very well and no signs of infection to report.

• Brand Name: MYOSURE 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: 9661942
• MDR Text Key: 178125461
• Report Number: 1222780-2020-00021
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2020

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: 10-401
• Device Catalogue Number: 10-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/03/2020
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention