MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SUCTION COAGULATOR HDSW 10FR; SUCTION COAGULATOR HANDSWITCHING 10 FR

Catalog Number	004125
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A dhr review was performed, and there is no evidence of device defect or malfunctions.
Event or Problem Description
It was reported that during a nasal procedure, the buttons on the hand held suction coagulator would continue to activate the device, after the doctor released the button the device.The doctor used footswitch activation to complete the procedure.There were no patient consequences reported.

• Brand Name: SUCTION COAGULATOR HDSW 10FR
• Common Device Name: SUCTION COAGULATOR HANDSWITCHING 10 FR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8148515
• Report Number: 1721194-2018-00062
• Device Sequence Number: 11293826
• Product Code: GEI
• UDI-Device Identifier: 10614559105146
• UDI-Public: 10614559105146
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 004125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/10/2018
• Patient Sequence Number: 1