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

Model Number 50-501XL

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported that on a myosure procedure on (b)(6) 2022, 13 seconds into the procedure the patient started bleeding profusely, the patient had a very large posterior fibroid that had previously been biopsied.Once the bleeding started the physician reduced the suction, removed the myosure and increased the pressure, the bleeding did not stop and approximately 500 ml of blood loss occurred.At this point the physician removed al instrumentation and monitored blood loss using swabs.The patient had to be admitted to the ward for observation and a balloon tamponade was placed and a venous cannula and tranexamic acid was given intravenously.The patient was kept under observation.Additional information received the patient is recovered and well.She didn´t require additional treatment and the injury was not related to the device.No concerns were raised regarding the functioning of the equipment, dr (b)(6) suggested the fibroid may have started to de-generate pre-operatively and therefore bleeding was more excessive than expected.Patient was advised she would need hysteroscopic resection in theatre after a period of medical treatment to shrink the fibroid.

Manufacturer Narrative

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.¨no concerns were raised regarding the functioning of the equipment, dr (b)(6) suggested the fibroid may have started to de-generate pre-operatively and therefore bleeding was more excessive than expected.¨.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICD
• 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: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 13982091
• MDR Text Key: 288511013
• Report Number: 1222780-2022-00105
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2022

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: 50-501XL
• Device Catalogue Number: 50-501XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• 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
• Patient Sex: Female