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

Model Number 50-501XL

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

Patient Problem Death (1802)

Event Date 02/13/2019

Event Type  Death  

Manufacturer Narrative

As of today the investigation is still in-progress.A follow-up will be filed as needed.Lot and serial numbers of the disposable device not provided by the complainant; therefore, the model number, catalog number, and expiration date is not known.The device has not yet been returned; therefore, a failure analysis of the complaint device cannot be completed.The manufacture date is not known.Device history record (dhr) review and sterile lot review were unable to be conducted for the disposable device.Internal complaint reference: (b)(4).

Event Description

It was initially reported on (b)(6) 2019 that the customer had called technical support for trouble shooting assistance.It was noted that during a myosure tissue removal procedure after 30 minutes of cutting the controller stopped.The staff powered off and restarted the controller multiple times before calling technical support.A second disposable device was opened, but nothing was showing on the display screen.The customer asked the applications specialist to hold on and then returned stating "the patient is not doing well and she needs to hang up." the applications specialist called the customer back after 40 minutes, but the customer stated she was unable to talk at that time.The applications specialist reached out to the customer's hologic representative to make him aware and to gather additional information.The representative also reached out to the customer for more information on the patient, but was told the customer could not discuss at that moment, but that the equipment needed to be returned.On (b)(6) 2019 it was reported that the patient had died.Additional information was obtained on (b)(6) 2019 during a conference call between hologic's medical director and the executive director of surgical services.It was reported that while the customer was on the phone with applications the patient began having "complications" described as oxygen desaturation.Resuscitation was unsuccessful and the patient expired.It was also confirmed that the aquilex fluid management system was used during the procedure and the manufacturer has been made aware of this event as well.According to the director of surgical services there was no evidence that the complication arose from use of the myosure or aquilex as neither was being used when the patient began having complications.The cause of death has not yet been provided.

Manufacturer Narrative

As of today the investigation is still in-progress.A follow-up will be filed as needed.The device has not yet been 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).

Manufacturer Narrative

As of today no additional information regarding this event has been received.The reported device has not been returned for evaluation.If additional information becomes available or the device is returned a follow-up will be filed.

• 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
• MDR Report Key: 8391024
• MDR Text Key: 137848552
• Report Number: 1222780-2019-00045
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K122498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 18J17R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/20/2019; 03/20/2019
• Supplement Dates FDA Received: 04/02/2019; 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT: SN (B)(4); MYOSURE CONTROL UNIT: SN (B)(4)
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 135