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

Catalog Number 10-401

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Event Description

Myosure instrument stayed in the open position when foot removed from pedal.No harm to the patient or tissue.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7968663
• MDR Text Key: 123819679
• Report Number: 7968663
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA