MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE CONTROL UNIT

Model Number	10-550
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).
Event or Problem Description
It was reported a physician performed myosure procedure for uterine tissue removal (exact date unknown) and the "surgeon claims that he saw flames in the interior of the controller".There were no injuries.
Additional Manufacturer Narrative
The investigation did not result in a malfunction.Internal reference complaint#: (b)(4).

• Brand Name: MYOSURE CONTROL UNIT
• Common Device Name: CONTROL UNIT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7141946
• Report Number: 1222780-2017-00295
• Device Sequence Number: 1109607
• Product Code: HIH
• UDI-Device Identifier: 15420045505124
• UDI-Public: (01)15420045505124
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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
• Operator of Device: Physician
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1