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

Model Number 10-550

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

At the tail end of procedure, the myosure device stopped working and could not be restarted.Yearly calibration was completed.Device sequestered after procedure, inspected and returned to manufacturer.A replacement unit has been received.No harm to the patient.

• Brand Name: MYOSURE TISSUE REMOVAL SYSTEMCONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 9720443
• MDR Text Key: 179762549
• Report Number: 9720443
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 85