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

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

Pt scheduled for hysteroscopy with biopsy endometrium, w/wo d&c.Myosure equipment was set up prior to the procedure and it passed the priming cycle.Once provider was ready for myosure device, it was noted that one of the myosure tubing parts was broken and started leaking.Myosure was removed from field and procedure completed without the device.No patient harm.Myosure sales rep was present at the time of procedure.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; marlborough MA 01752
• MDR Report Key: 16876899
• MDR Text Key: 314740735
• Report Number: MW5117262
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female