MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE REACH TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401FC

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/08/2022

Event Type  Injury  

Manufacturer Narrative

Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.3 devices were involved in this event reported under : 1222780-2022-00205, 1222780-2022-00206.

Event Description

It was reported that on (b)(6) 2022, a patient was admitted to the emergency room for the third time needing 3 units of blood.The patient was 66 years old and had been post-menopausal for 20 years but begun spotting last december and last month started hemorrhaging.The physician performed a hysteroscopy and pulled multiple clots with graspers, the physician was able to observe endometrial tissue and suspected as cancerous.The physician used a myosure device to remove endometrial tissue but could not confirm the diagnosis and reported that he was likely to give the patient a hysterectomy.The physician tried to use novasure to stop the hemorrhaging at least but could only get 11 seconds of the ablation as she was bleeding so much that the amount of blood clogged the filter.A second device was attempted to be used but due to the amount of blood failed the cavity initial assessment and due to the patient being over dilated.The procedure was ended, and the patient was kept under observation.No other information is available.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15180022
• MDR Text Key: 297407567
• Report Number: 1222780-2022-00207
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female