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

Model Number 10-550

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Type  malfunction  

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 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.

Manufacturer Narrative

The investigation did not result in a malfunction.Internal reference complaint#: (b)(4).

• Brand Name: MYOSURE CONTROL UNIT
• Type of Device: CONTROL UNIT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7141946
• MDR Text Key: 96120968
• Report Number: 1222780-2017-00295
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505124
• UDI-Public: (01)15420045505124
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1