MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE; HYSTEROSCOPE

Model Number 10-401

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Myosure tissue removal system device used in room did not work when md attempted to use on patient.The patient was not harmed.Defective device was removed and a new device obtained, connected, and checked with rep present.Per operating room (or) circulating rn: when device was plugged in, an error read on machine prior to use on patient.Vendor made aware and replacement on its way.There was no harm to the patient.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 8869058
• MDR Text Key: 153543085
• Report Number: 8869058
• 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: 07/25/2019,07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-401
• Device Catalogue Number: 10-401
• Device Lot Number: 19C19RJ
• 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: 07/25/2019
• Date Report to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA