MAUDE Adverse Event Report: HOLOGIC MYOSURE LITE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 30-401LITE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

Instrument continued running, even after md removed their foot from pedal.Device faulty.New device was opened to complete the case.Fda safety report id# (b)(4).

• Brand Name: MYOSURE LITE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC
• MDR Report Key: 15054464
• MDR Text Key: 296221763
• Report Number: MW5110939
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/14/2022

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 Catalogue Number: 30-401LITE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1