MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE; MYOSURE CONTROL UNIT/ HYSTEROSCOPE AND ACCESSORIES

Model Number RM-10-550

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Prior to start of a hysteroscopy dilation and curettage surgical case, myosure hysteroscopic tissue removal control unit tubing was primed with use of aquilex equipment.The case started; however, after about 40 mins into the procedure, the myosure device blade stopped functioning.The surgeon asked the primary circulator to retrieve a new myosure device.The myosure device and tubing were replaced, but again were noted to not be functioning.A sharp curettage was performed.The equipment was quarantined at that time and has been removed from service.

• Brand Name: MYOSURE
• Type of Device: MYOSURE CONTROL UNIT/ HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): HOLOGIC, INC.; marlborough MA 01752
• MDR Report Key: 8378377
• MDR Text Key: 137560677
• Report Number: MW5084504
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RM-10-550
• Device Catalogue Number: 10-550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 135