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

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

Patient Problem Death (1802)

Event Date 09/09/2019

Event Type  Death  

Manufacturer Narrative

Date of death is unknown.Brand name of device is unknown.Model number of device is unknown.Lot and serial 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.510k number is unknown.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

It was reported that a (b)(6) year old patient underwent an uncomplicated fibroid removal procedure.The deficit slowly rose to 2,000 ml by end of the procedure, but there were no "specific distension issues reported." post procedure, on same day, the patient complained of abdominal tenderness and did not "bounce back" as expected and subsequently remained at the facility for a remainder of time.When the tissue removed during the procedure was biopsied, a small portion of bowel was found in the tissue trap.Upon further observation, patient became septic and began to experience "the cardiac related issues," no details on specifics known.Later on, at an unknown date and time, the physician decided to perform an exploratory laparotomy.It was during this procedure that the patient expired.No hologic products were utilized during the laparotomy.Attempts to obtain additional information have been unsuccessful.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL
• 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: 9324449
• MDR Text Key: 166437806
• Report Number: 1222780-2019-00256
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• 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: AQUILEX, SN UNKNOWN
• Patient Outcome(s): Death; Hospitalization; Required Intervention