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

Model Number 30-401LITE

Patient Problem Insufficient Information (4580)

Event Date 11/17/2023

Event Type  Injury  

Event Description

Myosure not found when it was connected had to be taken out and placed back in multiple times.

• Brand Name: MYOSURE LITE POLYP REMOVAL SIMPLIFIED
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 18986603
• MDR Text Key: 338795434
• Report Number: MW5153210
• 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
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Device Model Number: 30-401LITE
• Device Lot Number: 22L24RB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White