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

Catalog Number 40-200

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/15/2024

Event Type  Injury  

Event Description

The power supply cord was on and the patient sustained a burn.

• Brand Name: MYOSURE HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC ,INC.
• MDR Report Key: 18809761
• MDR Text Key: 336695168
• Report Number: MW5152169
• 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: 02/23/2024

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 Catalogue Number: 40-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Patient Race: White