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

Model Number 10-401

Device Problems Loss of Power (1475); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 01/22/2016

Event Type  Injury  

Event Description

In the middle of the procedure, we heard a click and the device stopped working.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 5488888
• MDR Text Key: 39977338
• Report Number: 5488888
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 10-401
• Device Catalogue Number: 10-401
• Device Lot Number: 15K01R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1