MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL BTN HLSTR; E-Z CLEAN PENCIL BUTTON HOLSTER

Model Number	0035H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported by the rep during an exploratory laparotomy with the setting on 40.40 during the opening of the midline incision, the device was arching and flames were shooting out of the tip.A second device was tried, and it did the same thing.The patient had no implants or tattoos.The procedure was completed with a third like device with no patient consequences reported.

• Brand Name: E-Z CLEAN PNCL BTN HLSTR
• Common Device Name: E-Z CLEAN PENCIL BUTTON HOLSTER
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9589116
• Report Number: 1721194-2020-00013
• Device Sequence Number: 14081646
• Product Code: GEI
• UDI-Device Identifier: 10614559100493
• UDI-Public: 10614559100493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K965054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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 Model Number: 0035H
• Device Catalogue Number: 0035H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1