MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER MONOPOLAR FOOTSWITCH; MEGA POWER MONOPOLAR FOOT SWITCH

Catalog Number	1400JJ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, the device would fire even when the foot control was not pushed.Case completed with another foot pedal.There were no patient consequences reported.

• Brand Name: MEGAPOWER MONOPOLAR FOOTSWITCH
• Common Device Name: MEGA POWER MONOPOLAR FOOT SWITCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8356017
• Report Number: 1721194-2019-00080
• Device Sequence Number: 2034976
• Product Code: GEI
• UDI-Device Identifier: 10614559105269
• UDI-Public: 10614559105269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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 Catalogue Number: 1400JJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1