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

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

Metal bioburden or parts of instrument seen inside patient during myosure procedure.During the procedure, thin metal shaving/pieces were noted in the uterine cavity.The operative sheath was assumed responsible for producing which was replaced.

• Brand Name: MYOSURE - OPERATIVE SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 17949587
• MDR Text Key: 326008496
• Report Number: MW5147023
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female